Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
1,393
Countries
2
Sites
7
Alzheimer’s Disease
Time to clinically meaningful progression as measured by CDR
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
- 15 Apr 2025 → ongoing
- Decision date (initial)
- 2025-03-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515656-20-00
- WHO UTN
- U1111-1311-9148
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacokinetic, Pharmacogenetic, Pharmacodynamic, Therapy, Diagnosis, Pharmacoeconomic, Pharmacogenomic, Safety
Time to clinically meaningful progression as measured by CDR
Conditions and MedDRA coding
Alzheimer’s Disease
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
- be 55 to 80 years old
- have a reliable study partner
- have a screening biomarker blood test result that points to the presence of plaques in the brain
- have no or only mild problems with memory and function
Exclusion criteria 5
- have dementia or other significant disease of the brain that affects memory and thinking
- have a current serious medical condition or abnormality that could increase the risk to their safety or could interfere with the results of this study
- have a history of severe drug allergies or hypersensitivity reactions
- have certain health conditions that prevent them from getting an MRI
- have had recent treatment with a drug to remove plaque from the brain
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Time to Clinically Meaningful Progression as Measured by Clinical Dementia Rate (CDR). CDR is a clinician-rated scale that provides an overall assessment of the participant's stage and degree of impairment across the continuum of early Alzheimer's Disease (AD).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10036527 · Product
- Active substance
- LY3372993
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 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
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 9
| Organisation | City, country | Duties |
|---|---|---|
| Charles River Laboratories, Inc. ORL-000002483
|
Saint-Laurent Quebec, Canada | Laboratory analysis |
| Clinical Ink Inc. ORG-100042433
|
Horsham, United States | E-data capture |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Code 2 |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| Cogstate Inc. ORG-100045256
|
New Haven, United States | Other |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring |
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Laboratory analysis |
Locations
2 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Ireland | 0 | 1 | |
| Spain | Ongoing, recruitment ended | 43 | 6 |
| Rest of world
Argentina, United States, Australia, Canada, Brazil, Japan, United Kingdom, China, Korea, Republic of, Mexico, Taiwan
|
— | 1,350 | — |
Investigational sites
Barcelonabeta Brain Research Center
Neurology, Calle Wellington 30, 08005, Barcelona
Fundacio Ace Institut Catala De Neurociencies Aplicades
Neurology, Gran Via De Carles III 85 Bis, 08028, Barcelona
Hospital Universitario Quironsalud Madrid
Neurology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Policlinica Gipuzkoa S.A.
Neurology, Paseo Miramon 174, 20009, Donostia
Hospital Clinic De Barcelona
Neurology, Calle Villarroel 170, 08036, Barcelona
Hospital Victoria Eugenia De La Cruz Roja Espanola
Neurology, Avenida La Cruz Roja 1, 41009, Sevilla
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 |
|---|---|---|---|---|---|
| Spain | 2025-04-15 | 2025-04-15 | 2025-09-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 19 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-515656-20-00_Redacted | c |
| Protocol (for publication) | D4_Patient facing documents_Copyright statement | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K2_LAKI_Flyer_Master | 2.0 |
| Recruitment arrangements (for publication) | K2_LAKI_Inclusion-Exclusion-Cards_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_LAKI_Inclusion-Exclusion-Cards-OUS_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_LAKI_Info-Card-Study-Partner_Master | 1.0 |
| Recruitment arrangements (for publication) | K2_LAKI_Letter-Doctor-Referral_Master_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_LAKI_Poster_Master | 2.0 |
| Recruitment arrangements (for publication) | K2_LAKI_Trial-Brochure_Master_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Neuro_AD_Alzheimers-Brain-Changes | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adenda actividad opcional APOE_Redacted | 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_Partner_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Confidentiality Notice | 2.0 |
| Subject information and informed consent form (for publication) | L2_Patient card | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis _a_ENG_EU CT number_2024-515656-20-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis _b_ENG_EU CT number_2024-515656-20-00_Redacted | b |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_2024-515656-20-00_Redacted_ES | c |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-09 | Spain | Acceptable 2025-03-11
|
2025-03-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-09 | Spain | Acceptable | 2025-04-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-16 | Spain | Acceptable 2025-08-22
|
2025-08-25 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-30 | Spain | Acceptable 2025-11-18
|
2025-11-24 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-01-23 | Spain | Acceptable | 2026-02-17 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-03-12 | Spain | Acceptable 2026-04-27
|
2026-05-04 |