Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
1,232
Countries
2
Sites
17
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders
To assess the effect of donanemab versus placebo on clinical progression in participants with early symptomatic Alzheimer’s Disease
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 4 Dec 2025 → ongoing
- Decision date (initial)
- 2025-10-31
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-522340-40-00
- WHO UTN
- U1111-1324-8006
- ClinicalTrials.gov
- NCT05508789
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Efficacy, Therapy, Safety
To assess the effect of donanemab versus placebo on clinical progression in participants with early symptomatic Alzheimer’s Disease
Conditions and MedDRA coding
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Participants must have gradual and progressive change in memory function reported by participants or informants for ≥ 6 months
- Participants must have an MMSE score of 20 to 28 (inclusive) at screening
- Participants must meet amyloid scan (central read) criteria
- Participants must have a study partner who will provide written informed consent to participate
Exclusion criteria 1
- Participants must not have contraindications to MRI or PET scans
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change from Baseline on the Integrated Alzheimer’s Disease Rating Scale (iADRS) in at least one of the low-medium tau pathology population or no-very low and low-medium tau pathology populations. [Time Frame: Baseline, Week 76]
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10892678 · Product
- Active substance
- Donanemab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- IV INFUSION
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
SUB39441 · Substance
- Active substance
- Sodium Chloride Ph. Eur.
- Pharmaceutical form
- INJECTION
- Route of administration
- IV INFUSION
- Max daily dose
- 0
- Max total dose
- 0
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 4
PRD11581635 · Product
- Active substance
- Flortaucipir (18F)
- Substance synonyms
- Flortaucipir F 18, 7-(6-(F-18)FLUOROPYRIDIN-3-YL)-5H-PYRIDO(4,3-B)INDOLE, 18F-AV-1451, AV-1451 F-18, LY3191748, T807 F-18
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- IV INFUSION
- Max daily dose
- 9.10 Other
- Max total dose
- 9.10 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10008562 · Product
- Active substance
- Flortaucipir (18F)
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- IV INFUSION
- Max daily dose
- 9.10 Other
- Max total dose
- 9.10 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD173432 · Product
- Active substance
- Florbetapir (18F)
- Substance synonyms
- Florbetapir F 18, 18F-AV-45
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- IV INFUSION
- Max daily dose
- 7.43 Other
- Max total dose
- 29.72 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- AVID PHARMACEUTICALS INC
- Paediatric formulation
- No
- Orphan designation
- No
PRD10008535 · Product
- Active substance
- Florbetapir (18F)
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- IV INFUSION
- Max daily dose
- 7.43 Other
- Max total dose
- 29.72 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Third parties 14
| Organisation | City, country | Duties |
|---|---|---|
| Sahlgrenska University Hospital-Vaestra Goetalandsregionen ORG-100006518
|
Molndal, Sweden | Laboratory analysis |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other, Data management |
| R&G US Inc. ORG-100048358
|
North Potomac, United States | Code 10 |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other |
| Labcorp Early Development Laboratories Inc. ORG-100012865
|
Chantilly, United States | Laboratory analysis |
| Invicro LLC ORG-100046990
|
Needham, United States | Laboratory analysis |
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Laboratory analysis |
| Bioclinica Inc. ORG-100033079
|
Philadelphia, United States | Laboratory analysis |
| Clinical Trial Media Inc. ORG-100046339
|
Hauppauge, United States | Code 10 |
| Iqvia Biotech LLC ORG-100008704
|
Durham, United States | On site monitoring |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | Code 11 |
| Cogstate Inc. ORG-100045256
|
New Haven, United States | Other, Data management |
| Techdata Service Company LLC ORG-100047422
|
Kng Of Prussa, United States | Code 10 |
Locations
2 EU/EEA countries · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ongoing, recruitment ended | 135 | 9 |
| Spain | Ongoing, recruitment ended | 35 | 8 |
| Rest of world
Australia, China, Korea, Republic of, Taiwan, United Kingdom
|
— | 1,062 | — |
Investigational sites
Centrum Medyczne Neuroprotect
N/A, Ul. Klaudyny 16c, 1 Piętro, Warsaw
Ilkowski I Partnerzy sp.p. Lekarzy
N/A, Ul. Wierzbowa 2/2, 61-853, Poznan
Centrum Medyczne Neuromed Sp. z o.o.
N/A, Ul. Jana Biziela 14, 85-163, Bydgoszcz
Euromedis Sp. z o.o.
N/A, Ul. Powstancow Wielkopolskich 33 A, 70-111, Szczecin
Wrocławskie Centrum Alzheimerowskie
N/A, al. Gen. W. Sikorskiego 7 GHJ, 53-659 Wrocław, Wrocław
Centrum Badan Klinicznych Pi-House Sp. z o.o.
N/A, Ul. Na Zaspe 3, 80-546, Gdansk
Diamond Clinic Sp. z o.o.
N/A, Ul. Stefana Rogozinskiego 6/U3, 31-559, Cracow
Revit Sp. z o.o.
N/A, Ul. Swobodna 38, 15-756, Bialystok
Neuro-Care Sp. z o.o. sp.k.
N/A, Ul. Pawla Kolodzieja 8, 40-749, Katowice
Hospital Universitari De Santa Maria
Cognitive Impairment Unit, Av Alcalde Rovira Roure 44, 25198, Lleida
Hospital Clinic De Barcelona
Alzheimer's disease and other cognitive disorders unit, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Dr Peset Aleixandre
Neurology, Avinguda De Gaspar Aguilar 90, 46017, Valencia
Hospital Universitario Y Politecnico La Fe
Neurology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital De La Santa Creu I Sant Pau
Memory Unit, Carrer De San Quinti 89, 08041, Barcelona
Fundacio Ace Institut Catala De Neurociencies Aplicades
Neurology, Gran Via De Carles III 85 Bis, 08028, Barcelona
Hospital Universitari General De Catalunya
Neurology, Carrer Pedro I Pons 1, 08195, Sant Cugat Del Valles
Barcelonabeta Brain Research Center
Neurology, Calle De Wellington 30, 08005, 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 |
|---|---|---|---|---|---|
| Poland | 2025-12-05 | 2025-12-09 | 2026-04-29 | ||
| Spain | 2025-12-04 | 2025-12-05 | 2026-04-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 25 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-522340-40-00_Redacted | b |
| Protocol (for publication) | D4_Patient facing documents_Copyright statement | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_AACO_Poster_Master_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_AACO_Trial Brochure_PL_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter Doctor Referral | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trial Brochure_Redacted | 1 |
| Recruitment arrangements (for publication) | K4_Recruitment arrangments_Informed consent and patient recruitment procedure_PL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adenda acompanante | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adenda actividad opcional APOE | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adenda preseleccion | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_APOE disclosure ICF_PL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_Main ICF_AACO_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening ICF_PL | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening ICF_TC_PL | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Study Partner ICF_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Participant Contact Card | 1 |
| Subject information and informed consent form (for publication) | L4_Compensation Information Sheet_AACO_PL | 1 |
| Subject information and informed consent form (for publication) | L5_Info Re insurance Conditions for Patient | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG_2025-522340-40-00_Redacted | b |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2025-522340-40-00_Redacted | b |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PL_2025-522340-40-00_Redacted | b |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-09 | Poland | Acceptable with conditions 2025-10-27
|
2025-10-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-04 | Poland | Acceptable 2025-11-27
|
2025-11-30 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-16 | Acceptable 2025-11-27
|
2026-01-16 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-01-19 | Poland | Acceptable 2025-11-27
|
2026-01-19 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-01-28 | Poland | Acceptable 2026-03-20
|
2026-03-23 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-04-29 | Poland | Acceptable 2026-03-20
|
2026-04-29 |