Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
63
Countries
1
Sites
1
Early-onset Alzheimer's disease (EOAD)
Key facts
- Sponsor
- Alnylam Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 29 Jun 2022 → ongoing
- Decision date (initial)
- 2024-02-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508363-79-00
- EudraCT number
- 2021-003198-74
- ClinicalTrials.gov
- NCT05231785
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Early-onset Alzheimer's disease (EOAD)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 24.1 | LLT | 10086384 | Early onset Alzheimer´s disease | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Alnylam Pharmaceuticals Inc.
- Sponsor organisation
- Alnylam Pharmaceuticals Inc.
- Address
- 300 3rd Street
- City
- Cambridge
- Postcode
- 02142-1103
- Country
- United States
Scientific contact point
- Organisation
- Alnylam Pharmaceuticals Inc.
- Contact name
- Clinical Trials Information Line
Public contact point
- Organisation
- Alnylam Pharmaceuticals Inc.
- Contact name
- Clinical Trials Information Line
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 6 | 1 |
| Rest of world
United States, Canada, United Kingdom
|
— | 57 | — |
Investigational sites
Brain Research Center Amsterdam B.V.
Neurology, Cronenburg 2, 1081 GN, Amsterdam
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 |
|---|---|---|---|---|---|
| Netherlands | 2022-06-29 | 2024-02-05 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-25 | Netherlands | Acceptable 2024-02-05
|
2024-02-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-25 | Netherlands | Acceptable with conditions 2024-07-01
|
2024-07-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-25 | Netherlands | Acceptable 2025-07-03
|
2025-07-03 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-05 | Netherlands | Acceptable 2025-07-03
|
2026-03-05 |