Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
602
Countries
11
Sites
81
Agitation Associated with Alzheimer’s Disease
To assess the long-term safety and tolerability of KarXT + KarX-EC in participants with agitation associated with AD.
Key facts
- Sponsor
- Bristol-Myers Squibb Services Unlimited Company
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Decision date (initial)
- 2025-10-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-519994-20-00
- WHO UTN
- U1111-1316-3903
- ClinicalTrials.gov
- NCT06937229
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Others
To assess the long-term safety and tolerability of KarXT + KarX-EC in participants with agitation associated with AD.
Conditions and MedDRA coding
Agitation Associated with Alzheimer’s Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | LLT | 10066844 | Behavioral and psychiatric symptoms of dementia | 10037175 |
| 20.0 | PT | 10012271 | Dementia Alzheimer's type | 100000004852 |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration
- Plan to share IPD
- Yes
- IPD plan description
- BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- The participants who can participate in this study are those who have finished either study CN0120023 or CN0120024.
- Participants also must sign a new informed consent form and continue to have a caregiver who can continue to accompany them to all study visits, make sure they take their medication and follow the study rules, and agree to participate in interviews and questionnaires about the participant’s behavior (approximately 10 hours a week or more).
Exclusion criteria 1
- Participants must not have clinically significant cardiovascular (eg, untreated or unstable hypertension, clinically significant tachycardia), pulmonary, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Incidence of any Treatment-Emergent Adverse Events (TEAEs).
Secondary endpoints 9
- Reported adverse events (AEs), TEAEs, serious AEs, and TEAEs leading to study withdrawal and deaths
- AEs of special interest
- Assessment of abnormal involuntary movements or restlessness
- Body weight
- Blood pressure and heart rate
- Laboratory evaluations
- Suicidal ideation
- Assessment of cognition
- Assessment of urinary retention.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 8
PRD12404394 · Product
- Active substance
- Trospium Chloride
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD12404377 · Product
- Active substance
- Trospium Chloride
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD12404386 · Product
- Active substance
- Trospium Chloride
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 9999 mg/g milligram(s)/gram
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD12404368 · Product
- Active substance
- Trospium Chloride
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD12408422 · Product
- Active substance
- Xanomeline Tartrate
- Substance synonyms
- LY246708 tartrate, 3-(4-(Hexyloxy)-1,2,5-thiadiazol-3-yl)-1,2,5,6-tetrahydro-1-methylpyridine (-)-(+)-tartrate (1:1)
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg/g milligram(s)/gram
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD12408431 · Product
- Active substance
- Xanomeline Tartrate
- Substance synonyms
- LY246708 tartrate, 3-(4-(Hexyloxy)-1,2,5-thiadiazol-3-yl)-1,2,5,6-tetrahydro-1-methylpyridine (-)-(+)-tartrate (1:1)
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD12408423 · Product
- Active substance
- Xanomeline Tartrate
- Substance synonyms
- LY246708 tartrate, 3-(4-(Hexyloxy)-1,2,5-thiadiazol-3-yl)-1,2,5,6-tetrahydro-1-methylpyridine (-)-(+)-tartrate (1:1)
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD12408417 · Product
- Active substance
- Xanomeline Tartrate
- Substance synonyms
- LY246708 tartrate, 3-(4-(Hexyloxy)-1,2,5-thiadiazol-3-yl)-1,2,5,6-tetrahydro-1-methylpyridine (-)-(+)-tartrate (1:1)
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bristol-Myers Squibb Services Unlimited Company
- Sponsor organisation
- Bristol-Myers Squibb Services Unlimited Company
- Address
- Plaza 254, Blanchardstown Corporate Park 2 Blanchardstown Corporate Park 2
- City
- Dublin 15
- Postcode
- D15 T867
- Country
- Ireland
Scientific contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Public contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Central Laboratory Services Sàrl ORL-000005229
|
Geneva, Switzerland | Other |
| Endpoint Clinical Inc. ORL-000012879
|
Wakefield, United States | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Chennai, India | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Data management |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Other |
| Iqvia Inc. ORG-100010622
|
Durham, United States | Other |
Locations
11 EU/EEA countries · 81 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Authorised, recruitment pending | 8 | 5 |
| Croatia | Authorised, recruitment pending | 13 | 4 |
| Czechia | Authorised, recruitment pending | 21 | 7 |
| France | Authorised, recruitment pending | 17 | 7 |
| Greece | Authorised, recruitment pending | 18 | 8 |
| Hungary | Authorised, recruitment pending | 14 | 7 |
| Italy | Authorised, recruitment pending | 20 | 7 |
| Poland | Authorised, recruitment pending | 20 | 7 |
| Portugal | Authorised, recruitment pending | 8 | 5 |
| Romania | Authorised, recruitment pending | 25 | 13 |
| Spain | Authorised, recruitment pending | 29 | 11 |
| Rest of world
Taiwan, Israel, Chile, Korea, Republic of, Ukraine, Argentina, United States, Brazil, Japan, United Kingdom, China, India, Mexico, Canada
|
— | 409 | — |
Investigational sites
Diagnostics-Consultancy Center Mladost M Varna OOD
Psychiatry, Bulevard Republika 15, 9020, Varna
Outpatient Clinic for Indiv. Practice for Spec.Med. Care in Psychiatry-Dr.Madlena Dimitrova Borisova
Psychiatry, 2 Parkova Str., 7200, Razgrad
Mental Health Center Sofia EOOD
Department for active treatment of individuals with severe psychiatric disorders – Psychiatry, Level, Bulevard Slivnitsa 309, 1202, Sofia
Medical Center Saint Naum EOOD
Psychiatry, Ulitsa D-R Lyuben Rusev 1, 1113, Sofiya
Medical Center Medconsult Pleven OOD
Psychiatry, Floor 4, Ulitsa Sveti Sveti Kiril I Metodiy 18, Pleven
Clinical Hospital Centre Rijeka
Psychiatry, Kresimirova 42, 51000, Rijeka
Opca Bolnica Varazdin
Neurology, Ulica Ivana Mestrovica 1, 42000, Varazdin
KBC Split
Psychiatry, Spinciceva 1, 21000, Split
KBC Zagreb
Neurology, Ulica Mije Kispatica 12, Zagreb, Grad Zagreb
Neuro Health Centrum s.r.o.
NA, Hornikova 2485/34, Lisen, Brno-Lisen
Vestra Clinics s.r.o.
N/A, Jiraskova 1389, 516 01, Rychnov Nad Kneznou
INEP medical s.r.o.
N/A, Krizikova 264/22, Karlin, Prague
Neuropsychiatrie s.r.o.
N/A, Terronska 580/19, Bubenec, Prague 6
Neurohk s.r.o.
N/A, Smetanova 830, 565 01, Chocen
AGE Centrum s.r.o.
N/A, Na Sibeniku 914/1 Nova Ulice, 779 00, Olomouc
A-Shine s.r.o.
N/A, Sumavska 2, Vychodni Predmesti, Plzen 3
Centre Hospitalier Universitaire De Montpellier
Neurology, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire De Toulouse
Gerontopole Clinical Research Center, Place Lange, 31059, Toulouse Cedex 9
Centre Hospitalier Et Universitaire De Limoges
Geriatric Medicine, 2 Avenue Martin Luther King, 87000, Limoges
Centre Hospitalier Universitaire De Lille
Memory center for Resources and Research, Avenue Du Professeur Emile Laine, 59037, Lille Cedex
Hospices Civils De Lyon
Geriatric Medicine, 27 Rue Gabriel Peri, 69100, Villeurbanne
Assistance Publique Hopitaux De Paris
cognitive neurology center, 200 Rue Du Faubourg Saint Denis, 75010, Paris
Les Hopitaux Universitaires De Strasbourg
Memory center for Resources and Research, 21 Rue David Richard, 67000, Strasbourg
Euromedica General Clinic Of Thessaloniki
Neurological Department, Kallas Marias 11, Gravias 2, Thessaloniki
General University Hospital Of Patras
Department of Neurology, Rio, 265 04, Patras
Henry Dunant Hospital Center
2nd Neurological Clinic, 107 Mesogeion Avenue, 115 26, Athens
Eginitio Hospital
A’ Department of Neurology, Vassilissas Sofias Avenue 74, 115 28, Athens
University General Hospital Of Ioannina
Department of Neurology, Niarchou Stavrou Avenue, 455 00, Ioannina
University General Hospital Attikon
2nd Department of Neurology, Rimini Street 1, 124 62, Athens
Eginitio Hospital
First Department of Psychiatry, Vassilissas Sofias Avenue 74, 115 28, Athens
Athens Medical Center S.A.
Memory Clinic, Distomou 5-7, 151 25, Maroussi
Clinexpert Kft.
N/A, Kaszasdulo Utca 5, 1033, Budapest III
Gyoengyosi Bugat Pal Koerhaz
Pszichiatria, Dozsa Gyorgy Utca 20-22, 3200, Gyongyos
University Of Debrecen
Neurologiai Klinika, Bartok Bela Ut 2-26, 4031, Debrecen
Dr. Mathe Es Tarsa Bt.
N/A, Szechenyi Ut 8, 6300, Kalocsa
Obudai Egeszseguegyi Centrum Kft.
N/A, Kodaly Zoltan Utca 8/ A, 2400, Dunaujvaros
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Pszichiatria, Vasvari Pal Utca 2-4, 9024, Gyor
Semmelweis University
Neurologiai Klinika, Balassa J Utca 6, 1083, Budapest
Istituto Auxologico Italiano
Neurology, Piazzale Brescia 20, 20149, Milan
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
S.C. Neurologia, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Ospedaliero-Universitaria Sant Andre
NESMOS, Via Di Grottarossa 1035-1039, 00189, Rome
Azienda Ospedaliera Universitaria Federico II Di Napoli
Neuroscience, Via Sergio Pansini 5, 80131, Naples
Azienda Ospedaliero Universitaria Pisana
UO Psichiatria, Via Roma 67, 56126, Pisa
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Medicina Interna Geriatrica, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Neuroscienze, Viale Del Policlinico 155, 00161, Rome
Centrum In Psyche Spersonalizowanej Psychiatrii I Terapii
N/A, ul. Prof. Jana Mikusinskiego 1/1, 40-146, Katowice
Rcmed Oddzial Sochaczew
N/A, Aleja 600-Lecia 45, 96-500, Sochaczew
Centrum Medyczne Neuromed Sp. z o.o.
N/A, Ul. Jana Biziela 14, 85-163, Bydgoszcz
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.
N/A, Ul. Polnocna 8/3, 20-064, Lublin
Instytut Naukowo-Badawczy Sp. z o.o.
M&D Centrum Medyczne, ul. Polnocna 20, 20-064, Lublin
Centrum Medyczne Hcp Sp. z o.o.
N/A, Ul. 28 Czerwca 1956 R. 194, 61-485, Poznan
M2M Med. Sp. z o.o. Sp. j.
N/A, Ul. Lwowska 34, 41-500, Chorzow
Unidade Local De Saude De Matosinhos E.P.E.
Neurology, Rua Doutor Eduardo Torres, 4464-513, Senhora Da Hora
Unidade Local De Saude Do Alto Ave E.P.E.
Neurology, Rua Dos Cuteleiros De Guimaraes, 4835-044, Guimaraes
Unidade Local De Saude De Coimbra E.P.E.
Neurology, Praceta Professor Mota Pinto, 3004-561, Coimbra
Unidade Local De Saude De Santa Maria E.P.E.
Neurology, Avenida Professor Egas Moniz, 1649-035, Lisbon
CNS Saude Lda.
Neurology, Bairro De Santo Antonio 47, 2560-280, Torres Vedras
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila
Psychiatry, Calea Plevnei Nr. 134, 010242, Bucharest
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Psychiatry, Soseaua Berceni 10, 041915, Bucharest
Spitalul Clinic De Psihiatrie Dr. Gheorghe Preda Sibiu
Psychiatry, Strada Doctor Dumitru Bagdazar Nr 12, 550082, Sibiu
Institutul De Psihiatrie Socola Iasi
Psychiatry, Soseaua Bucium 36, 700282, Jassi
Spitalul Clinic Cai Ferate Constanta
Neurology, Bulevardul 1 Mai 5-7, 900123, Constanta
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Psychiatry, Soseaua Berceni 10, 041915, Bucharest
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Psychiatry, Strada Argeselu Nr 8, 040874, Bucharest
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Psychiatry, Soseaua Berceni 10, 041915, Bucharest
Centrul de Evaluare și Tratament a Toxicodependenței pentru Tineri Sf.Stelian
Psychiatry, Strada Pascal Cristian, Nr. 25-27, Bucuresti
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Psychiatry, Soseaua Berceni 10, 041915, Bucharest
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Psychiatry, Soseaua Berceni 10, 041915, Bucharest
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Psychiatry, Soseaua Berceni 10, 041915, Bucharest
Spitalul Clinic De Psihiatrie Si Neurologie Brasov
Psychiatry, Strada Prundului 7-9, 500123, Brasov
Hospital Ruber Juan Bravo
Neurologia, Calle De Juan Bravo 49, 28006, Madrid
Clinica Universidad De Navarra
Neurologia, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Victoria Eugenia De La Cruz Roja Espanola
Neurologia, Avenida La Cruz Roja 1, 41009, Sevilla
Fundacio Assistencial De Mutua De Terrassa Fpc
Neurologia, Calle De San Antonio No 32, 08221, Terrassa
Hospital Universitario De Salamanca
Neurologia, Paseo De San Vicente 58-182, 37007, Salamanca
Oroitu S.L.
Neurologia, Jata Kalea 8, 48993, Getxo
Hospital Universitario Rio Hortega
Neurologia, Calle Dulzaina 2, 47012, Valladolid
Hospital Clinico San Carlos
Neurologia, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital Universitario Virgen De La Victoria
Neurologia, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Clinica Montecanal S.L.
Neurologia, Calle Franz Schubert 2, 50012, Zaragoza
Hospital General Universitario De Elche
Neurologia, Edificio 2, Camino De La Almazara 11, Elche
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 117 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-519994-20-00 GR_Redacted | 01 |
| Protocol (for publication) | D1_Protocol 2024-519994-20-00_redacted | PA 01 |
| Protocol (for publication) | D4_patient facing documents__statement_under license PL | N/A |
| Protocol (for publication) | D4_Patient facing Documents_Questionnaire ADAS-Cog WL1_PT | 1 |
| Protocol (for publication) | D4_Patient facing Documents_Questionnaire ADAS-Cog WL2_PT | 1 |
| Protocol (for publication) | D4_Patient facing Documents_Questionnaire ADAS-Cog WL3_PT | 1 |
| Protocol (for publication) | D4_Patient facing Documents_Questionnaire ADAS-Cog WL5_PT | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_ADAS-Cog_WL1_BG | NA |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_ADAS-Cog_WL2_BG | NA |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_ADAS-Cog_WL3_BG | NA |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_ADAS-Cog_WL5_BG | NA |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_ADAS-COG_wordlist-recall_L1-2-3-4-5-6_TS6_0_bul-BG_1 | NA |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_ADAS-COG-wordlist-recall_L1-2-3-4-5-6_TS6_0_bul-BG_2 | NA |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_ADAS-COG-wordlist-recognition_L1-2-3-4-5-6_T1_TS6 0_bul-BG | NA |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_AIMS_BG | NA |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_BARS_BG | NA |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_C-SSRS_BL_BG | NA |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_IPSS_BG | NA |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_MMSE_BG | NA |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_Statement for publication_ES | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_Statement for publication_IT | na |
| Protocol (for publication) | D4_Patient facing documents_Statement on validated questionnaires under license_HR | 1 |
| Protocol (for publication) | D4_patient facing documents_statement_under license_BG | NA |
| Protocol (for publication) | D4_patient facing documents_statement_under license_GR | NA |
| Protocol (for publication) | D4_Statement on validated questionnaires under licence_CZ | N/A |
| Protocol (for publication) | D4_Statement on validated questionnaires under licence_FR | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under licence_RO | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_ENG | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_HU | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_PT | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements_GR | 1.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_HR | 1 |
| Recruitment arrangements (for publication) | K1_BG_Recruitment arrangements_bg_23Jun2025 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure template | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_CZ | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FR | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_IT | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Greenphire_HR_Unedacted | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Main ICF_HR_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Optional Future Research_HR_Unredacted | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Pregnant Participant_HR_Unredacted | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Study Partner_HR_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Assent_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Optional Future Research | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Study Partner_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_Greenphire ICF for Bulgaria_BG_V1_0_23Jun2025 | 1 |
| Subject information and informed consent form (for publication) | L1_Greenphire ICF for Bulgaria_EN_V1_0_23Jun2025 | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Genetic_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult Assent_BG_v1_24Jun2025_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult Assent_EN_v1_24Jun2025_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult Assent_IT_Redatto | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Asentimiento_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent_FR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent_GR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent_PL_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent_PT_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Cuidador de Paciente_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF General_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Investigacion Futura Opcional_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main for Bulgaria_BG_v1_24Jun2025_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main for Bulgaria_EN_v1_24Jun2025_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF_PT_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_GR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_IT_Redatto | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_PL_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted_FR | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_BG_v1_23Jun2025 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_EN_v1_23Jun2025 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_FR | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_GR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF optional Future Research_IT_Redatto | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_PL | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_PT_Unredacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_FR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Privacy_IT_Redatto | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reimbursement_GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reimbursement_IT_Redatto | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Study Partner _GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Study Partner PL_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Study Partner_BG_v1_23Jun2025_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Study Partner_EN_v1_23Jun2025_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Study Partner_IT_Redatto | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Study Partner_PT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Study Partner_Redacted_FR | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult Assent_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_already enrolled participant_CZ_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_new participant_CZ_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Caregiver_CZ_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_already enrolled participant_CZ_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_new participant_CZ_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional future Research redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Participant Card | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Study Partner_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS Genetic redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IOCBP_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Persona Data_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Participant Alert Card_FR_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1 Protocol synopsis EU CTR 2024-519994-20_PL | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis 2024-519994-20-00 GR | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-519994-20 BG | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-519994-20_CZ | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-519994-20_FR | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-519994-20_HU | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-519994-20_IT | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-519994-20_PT | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-519994-20-00_ES | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ENG_2024-519994-20-00 | 04 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU CT2024-519994-20_HR | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_EU CTR 2024-519994-20_RO | 4 |
| Synopsis of the protocol (for publication) | D4_Patient Facing Documents_Questionnaire_ADAS-COG-wordlist-recognition_ES | 1 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-30 | Poland | Acceptable with conditions 2025-10-20
|
2025-10-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-14 | Acceptable with conditions | 2025-11-25 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-27 | Poland | Acceptable with conditions | 2025-11-27 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-22 | Poland | Acceptable 2026-04-03
|
2026-04-06 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-04-24 | Acceptable 2026-04-03
|
2026-04-24 |