Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
1,757
Countries
3
Sites
20
Alzheimer Disease
To assess the effect of donanemab versus placebo on clinical progression in participants with early symptomatic AD
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 30 Sep 2020 → 17 Sep 2025
- Decision date (initial)
- 2024-10-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507303-55-00
- EudraCT number
- 2020-000077-25
- ClinicalTrials.gov
- NCT04437511
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacogenetic, Pharmacokinetic, Safety, Therapy, Efficacy, Pharmacodynamic
To assess the effect of donanemab versus placebo on clinical progression in participants with early symptomatic AD
Conditions and MedDRA coding
Alzheimer Disease
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months
- MMSE score of 20 to 28 (inclusive) at baseline
- Meet 18F flortaucipir PET scan (central read) criteria - does not apply to safety cohort
- Meet 18F florbetapir PET scan (central read) criteria
- Have a study partner who will provide written informed consent to participate
Exclusion criteria 2
- Contraindication to MRI or PET scans
- Current treatment with immunoglobulin G (IgG) therapy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10892678 · Product
- Active substance
- Donanemab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFUSION
- Max daily dose
- 1400 mg milligram(s)
- Max total dose
- 51100 mg milligram(s)
- Max treatment duration
- 150 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
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
Auxiliary 2
PRD10008535 · Product
- Active substance
- Florbetapir (18F)
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFUSION
- Max daily dose
- 7.43 mCi millicurie(s)
- Max total dose
- 52.01 mCi millicurie(s)
- Max treatment duration
- 154 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
- INFUSION
- Max daily dose
- 9.1 mCi millicurie(s)
- Max total dose
- 27.3 mCi millicurie(s)
- Max treatment duration
- 154 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 28
| Organisation | City, country | Duties |
|---|---|---|
| Iqvia Biotech LLC ORG-100008704
|
Durham, United States | On site monitoring |
| TrIfecta Multimedia, LLC ORL-000010141
|
Indianapolis, United States | Other |
| Tier 1 Impact Pbc Inc. ORG-100050163
|
Covington, United States | Other |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Techdata Service Company LLC ORG-100047422
|
Kng Of Prussa, United States | Code 10 |
| Simpleshow USA Corp. ORG-100044593
|
Miami, United States | Other |
| Invicro also known as Konica Minolta, Inc. (parent company: Molecular NeuroImaging, LLC) ORL-000000242
|
London, United Kingdom | Laboratory analysis |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Oracle America Inc. ORG-100039874
|
Redwood City, United States | Data management |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | Data management |
| Cogstate Inc. ORG-100045256
|
New Haven, United States | Other, Data management |
| Reify Health Inc. ORG-100049669
|
Boston, United States | Other |
| Quanterix Corp. ORG-100044008
|
Billerica, United States | Laboratory analysis |
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Laboratory analysis |
| Macrostat (Shanghai) Clinical Research Co. Ltd. ORG-100048828
|
Shanghai, China | Code 10 |
| The Hibbert Co. ORG-100047639
|
Trenton, United States | Other |
| Research Square ORL-000010133
|
Durham, United States | Other |
| Iqvia Biotech LLC ORG-100008704
|
Durham, United States | Laboratory analysis |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | Code 11 |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | Other |
| Clinical Trial Media Inc. ORG-100046339
|
Hauppauge, United States | Other |
| C2n Diagnostics LLC ORG-100049457
|
Saint Louis, United States | Laboratory analysis |
| Trendyminds LLC ORG-100045580
|
Indianapolis, United States | Other |
| Teckro Limited ORG-100041454
|
Limerick, Ireland | Other |
| Iqvia Biotech LLC ORG-100008704
|
Durham, United States | Code 2 |
| Azenta US Inc. ORG-100012907
|
Indianapolis, United States | Other |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Laboratory analysis |
Locations
3 EU/EEA countries · 20 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 30 | 3 |
| Netherlands | Ended | 21 | 3 |
| Poland | Ended | 173 | 14 |
| Rest of world
United States, Japan, United Kingdom, Canada, Australia
|
— | 1,533 | — |
Investigational sites
A-Shine s.r.o.
N.A, Sumavska 2, Vychodni Predmesti, Plzen 3
Fakultní nemocnice v Motole
Neuropsychiatrie s.r.o., Terronska 580/19, Praha 6
Ústřední vojenská fakultní nemocnice
Neuropsychiatrie, Kolejní 5, Praha 6
Brain Research Center Zwolle B.V.
Brain Research Center, Dokter Stolteweg 90, 8025 AZ, Zwolle
Brain Research Center Den Bosch B.V.
Brain Research Center, Statenlaan 37, 5223 LA, 's-Hertogenbosch
Brain Research Center Amsterdam B.V.
Brain Research Center, Cronenburg 2, 1081 GN, Amsterdam
Osrodek Badawczo Naukowo Dydaktyczny Chorob Otepiennych Im. Ksiedza Henryka Kardynala Gulbinowicza Osrodek Alzheimerowski Sp. z o.o.
NA, Ul. Jana Pawla II Nr 12, 59-330, Scinawa
Euromedis Sp. z o.o.
NA, Ul. Powstancow Wielkopolskich 33 A, 70-111, Szczecin
Neuro-Care Sp. z o.o. sp.k.
NA, Ul. Szpitalna 6, 41-100, Siemianowice Slaskie
Klimed MK Sp. z o.o.
NA, Aleja Jana Pawla II 59/6u, 15-704, Bialystok
Futuremeds Sp. z o.o.
NA, Ul. Sapiezynska 3, 00-215, Warsaw
Centrum Medyczne Senior
NA, Ul. Rzemieslnicza 3, 81-855, Sopot
Centrum Medyczne Neuromed Sp. z o.o.
NA, Ul. Jana Biziela 14, 85-163, Bydgoszcz
Wrocławskie Centrum Alzheimerowskie (WCA)
NA, Generała Władysława Sikorskiego, local 7h, Wroclaw
Podlaskie Centrum Psychogeriatrii
NA, ul. Swobodna 38 lok 9, 15-756, Białystok
Centrum Medyczne Neuroprotect
NA, Ul. Klaudyny 16c, 1 Piętro, Warsaw
Ilkowski I Partnerzy sp.p. Lekarzy
NA, Ul. Wierzbowa 2/2, 61-853, Poznan
Centrum Badan Klinicznych Pi-House Sp. z o.o.
NA, Ul. Na Zaspe 3, 80-546, Gdansk
Diamond Clinic Sp. z o.o.
NA, Ul. Stefana Rogozinskiego 6/U3, 31-559, Cracow
Clinirem Sp. z o.o.
NA, Ul. Polnocna 24/U1, 20-064, Lublin
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 |
|---|---|---|---|---|---|
| Czechia | 2021-06-24 | 2025-08-13 | 2021-06-25 | 2021-07-23 | |
| Netherlands | 2020-12-04 | 2025-07-14 | 2021-02-05 | 2021-07-23 | |
| Poland | 2020-09-30 | 2025-09-17 | 2020-10-05 | 2021-07-23 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 32 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Clinical study report (for publication) | LY3002813 AACI 04 CSR Synopsis and Body_Redacted | 1 |
| Protocol (for publication) | D1_Protocol 2023-507303-55-00_redacted | f |
| Protocol (for publication) | D4_Patient facing documents_Copyright statement | 1 |
| Recruitment arrangements (for publication) | Blank document for Recruitment Arrangement_Recruitment closed | N.A |
| Recruitment arrangements (for publication) | Blank document for Recruitment Arrangement_Recruitment closed | N/A |
| Recruitment arrangements (for publication) | Blank document for Recruitment Arrangement_Recruitment closed | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Add for partner | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Add for patient | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum ICF Initial Screening_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Initial prescreening_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_AS_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Amendment Summary | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Data Privacy Addendum caregiver | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Data Privacy Addendum patient | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Extension Period_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Study Partner | 5.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Greenphire_Redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF | 9.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 9.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_TC_Redacted | 9.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main NG_Redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Partner Greenphire_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Partner NG_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Screening_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Study Partner ICF | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_AACI-Addendum_Visit_Card_Master | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_AACI-Visit-Card-Master | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Confidentiality Notice Netherlands | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_insurance conditions | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_patient card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Information Card CZ | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Subject Thank You Card | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-02 | Netherlands | Acceptable with conditions 2024-10-01
|
2024-10-01 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-23 | Netherlands | Acceptable with conditions 2024-10-01
|
2025-01-23 |