Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
240
Countries
2
Sites
11
Mild Alzheimer's disease
To evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of ABBV-552 once daily for the treatment of dementia due to mild Alzheimer's disease (AD)
Key facts
- Sponsor
- Abbvie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 12 Sep 2023 → 12 Sep 2024
- Decision date (initial)
- 2023-06-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- AbbVie Inc.
External identifiers
- EU CT number
- 2022-501918-55-00
- ClinicalTrials.gov
- NCT05771428
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Efficacy, Dose response, Pharmacokinetic, Safety
To evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of ABBV-552 once daily for the treatment of dementia due to mild Alzheimer's disease (AD)
Conditions and MedDRA coding
Mild Alzheimer's disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10001896 | Alzheimer's disease | 10029205 |
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screening Period A Screening Period of approximately 30 days when procedures required to evaluate participant eligibility and cognitive assessments will be conducted but no study treatment is provided.
|
Not Applicable | None | Screening Period: A Screening Period of approximately 30 days where no study treatment is provided. | |
| 2 | Double-Blind Treatment Period A 12 weeks double-blind treatment period where participants will be randomized in a 1:1:1:1 ratio to receive 1 of 3 doses of ABBV-552 or placebo to be taken once daily.
|
Randomised Controlled | Double | [{"id":73131,"code":5,"name":"Carer"},{"id":73127,"code":1,"name":"Subject"},{"id":73129,"code":4,"name":"Analyst"},{"id":73128,"code":2,"name":"Investigator"},{"id":73130,"code":3,"name":"Monitor"}] | ABBV-552 Dose A: Participants will receive ABBV-552 Dose A once daily (QD) for 12 weeks. ABBV-552 Dose B: Participants will receive ABBV-552 Dose B QD for 12 weeks. ABBV-552 Dose C: Participants will receive ABBV-552 Dose C QD for 12 weeks. Placebo for ABBV-552: Participants will receive placebo for ABBV-552 QD for 12 weeks. |
| 3 | Safety Follow-Up Period A safety follow-up period of 30 days where no study treatment is given
|
Not Applicable | None | Safety Follow-Up Period: A safety follow-up period of 30 days where no study treatment is given. |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Participants between 50 and 90 years of age, inclusive, with a diagnosis of probable Alzheimer's disease according to the National Institute of Aging-Alzheimer's Association (NIA-AA) (2011) criteria.
- Mini-Mental State Examination (MMSE) score of 20 to 26, a Clinical Dementia Rating (CDR) global score of 0.5 or 1.0, with a CDR memory score of 0.5 or higher, and at least 1 CDR functional domain (community affairs, home and hobbies, or personal care) score of 0.5 or higher at Screening Visit 1.
Exclusion criteria 1
- Clinically significant and/or unstable medical conditions or any other reason that the investigator determines would interfere with participation in this study (e.g., unlikely to adhere to the study or procedures, keep appointments, or is planning to relocate during the study) or would make the participant an unsuitable candidate to receive ABBV-552.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint is the change from Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 14) score at Week 12.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD10201314 · Product
- Active substance
- (4R-1-5-CHLORO-1H-124-TRIAZOL-1-YLMETHYL-4-345-TRIFLUOROPHENYL-2-PYRROLIDINONE
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 1275 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
PRD10201315 · Product
- Active substance
- (4R-1-5-CHLORO-1H-124-TRIAZOL-1-YLMETHYL-4-345-TRIFLUOROPHENYL-2-PYRROLIDINONE
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 1275 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
PRD10201316 · Product
- Active substance
- (4R-1-5-CHLORO-1H-124-TRIAZOL-1-YLMETHYL-4-345-TRIFLUOROPHENYL-2-PYRROLIDINONE
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 1275 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
Placebo for abbv-552 capsules 1mg, 5mg and 10mg
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Abbvie Deutschland GmbH & Co. KG
- Sponsor organisation
- Abbvie Deutschland GmbH & Co. KG
- Address
- Knollstrasse
- City
- Ludwigshafen Am Rhein
- Postcode
- 67061
- Country
- Germany
Scientific contact point
- Organisation
- Abbvie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Public contact point
- Organisation
- Abbvie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Third parties 10
| Organisation | City, country | Duties |
|---|---|---|
| Qd Solutions Inc. ORG-100041849
|
Austin, United States | Other |
| Labcorp Central Laboratory Services S.a.r.l. Meyrin ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Altoida Inc. ORG-100044896
|
Washington, United States | Other |
| Labcorp Endpoint Clinical Inc. ORG-100040567
|
Wakefield, United States | Interactive response technologies (IRT) |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | E-data capture |
| eResearchTechnology GmbH ORG-100044103
|
Estenfeld, Germany | Other |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| C2N Diagnostics, LLC ORL-000000514
|
Saint Louis, United States | Laboratory analysis |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
Locations
2 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 16 | 4 |
| Spain | Ended | 28 | 7 |
| Rest of world
Australia, United Kingdom, United States, New Zealand, Japan
|
— | 196 | — |
Investigational sites
Charite Universitaetsmedizin Berlin KöR
MVZ - Neurology, Hindenburgdamm 30, Lichterfelde, Berlin
Katholisches Klinikum Bochum gGmbH
Klinik für Neurologie, Gudrunstrasse 56, Grumme, Bochum
University Of Saarland
Klinik fuer Psychiatrie und Psychotherapie, Kirrberger Strasse, 66421, Homburg
Goethe University Frankfurt
Klinik fuer Psychiatrie, Psychosomatik und Psychotherapie, Heinrich-Hoffmann-Strasse 10, Niederrad, Frankfurt Am Main
Fundacio Assistencial De Mutua De Terrassa
N/A, Calle De San Antonio No 32, 08221, Terrassa
Hospital Universitario Marques De Valdecilla
N/A, 5 Planta, Avenida Valdecilla S/n, Santander
University Clinic Of Navarra
N/A, Pio XII Etorbidea 36, 31008, Pamplona
University Clinic Of Navarra
N/A, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario De Salamanca
N/A, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Ruber Internacional
N/A, Calle La Maso 38, 28035, Madrid
Hospital Universitari General De Catalunya
N/A, Calle Pedro I Pons 1, 08195, Barcelona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2023-10-09 | 2024-08-20 | 2023-11-23 | 2024-04-08 | |
| Spain | 2023-09-12 | 2024-09-05 | 2023-10-04 | 2024-05-14 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| CTIS M23-515 Final Results SUM-94542
|
2025-08-15T16:46:41 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| M23-515 Results Lay Summary | 2025-09-02T16:08:17 | Submitted | Laypersons Summary of Results |
Documents 27 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | m23515-results-lay-summary-de-de | 1 |
| Laypersons summary of results (for publication) | m23515-results-lay-summary-en-en | 1 |
| Laypersons summary of results (for publication) | m23515-results-lay-summary-es-es | 1 |
| Protocol (for publication) | ADAS-Cog Response Form-Maze A2-D2_public | 1 |
| Protocol (for publication) | ADAS-Cog_public | 1 |
| Protocol (for publication) | M23-515-protocol_redacted_public | 5.0 |
| Recruitment arrangements (for publication) | M23-515_DE_Ad and Recruitment Materials-Caregiver Brochure German_public | 1 |
| Recruitment arrangements (for publication) | M23-515_DE_Recruitment and ICF Procedures-Country_public | 1 |
| Recruitment arrangements (for publication) | M23-515_DE-Ad and Recruitment Materials-Flyer German_public | 1 |
| Recruitment arrangements (for publication) | M23-515_DE-Ad and Recruitment Materials-Physician to Patient Letter German_public | 1 |
| Recruitment arrangements (for publication) | M23-515_DE-Ad and Recruitment Materials-Recruitment Brochure German_public | 1 |
| Recruitment arrangements (for publication) | M23-515_ES_Ad and Recruitment Materials-Caregiver Brochure-Spanish_public | v1, rev 2 |
| Recruitment arrangements (for publication) | M23-515_ES_Ad and Recruitment Materials-Flyer-Spanish-public | 1 |
| Recruitment arrangements (for publication) | M23-515_ES_Ad and Recruitment Materials-Physician to Patient letter-Spanish_public | 1 |
| Recruitment arrangements (for publication) | M23-515_ES_Ad and Recruitment Materials-Recruitment Brochure-Spanish-public | 1 |
| Recruitment arrangements (for publication) | M23-515_ES_Recruitment and ICF Procedures-Study-public | 1 |
| Subject information and informed consent form (for publication) | L1_M23-515 DE ICF Main German_public redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_M23-515_ES_ICF main_Public Redacted | 5.0 |
| Subject information and informed consent form (for publication) | M23-515 DE ICF Study Partner ICF German_public | 2.0 |
| Subject information and informed consent form (for publication) | M23-515 DE ICF Submission Informed Consent Pregnant Partner German_public | 1 |
| Subject information and informed consent form (for publication) | M23-515 ES - ICF Pregnancy Spanish_public | 1 |
| Subject information and informed consent form (for publication) | M23-515 ES ICF Assent Country Sample Spanish_public | 1 |
| Subject information and informed consent form (for publication) | M23-515 ES ICF PregPart Country Sample Spanish_public | 2.0 |
| Subject information and informed consent form (for publication) | M23-515_ES_ICF Caregiver_public | 2.0 |
| Summary of results (for publication) | CTIS M23-515 Final Results | 1 |
| Synopsis of the protocol (for publication) | M23-515_ES_Protocol Synopsis-Global-Spanish_public-Redacted | 5.0 |
| Synopsis of the protocol (for publication) | M23-515-protocol-synopsis_public-Redacted | 5.0 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-09 | Germany | Acceptable 2023-06-26
|
2023-06-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-07-10 | Acceptable | 2023-07-27 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-10-31 | Germany | Acceptable | 2023-10-31 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-02-09 | Germany | Acceptable 2024-03-14
|
2024-03-15 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-05-21 | Germany | Acceptable 2024-03-14
|
2024-05-21 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-05-30 | Germany | Acceptable 2024-07-04
|
2024-07-05 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-08-21 | Germany | Acceptable 2024-10-01
|
2024-10-02 |