Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
50
Countries
2
Sites
6
Alzheimer’s Disease
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]
- Decision date (initial)
- 2026-02-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Alzheimer’s Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10001896 | Alzheimer's disease | 10029205 |
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
- Alnylam Clinical Trial Information Line
Public contact point
- Organisation
- Alnylam Pharmaceuticals Inc.
- Contact name
- Alnylam Clinical Trial Information Line
Locations
2 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 7 | 3 |
| Spain | Authorised, recruitment pending | 8 | 3 |
| Rest of world
Canada, United Kingdom
|
— | 35 | — |
Investigational sites
Amsterdam UMC Stichting
Neurology, De Boelelaan 1117, 1081 HV, Amsterdam
Brain Research Center Amsterdam B.V.
Neurology, Cronenburg 2, 1081 GN, Amsterdam
Brain Research Center Den Bosch B.V.
Neurology, Statenlaan 37, 5223 LA, 's-Hertogenbosch
Hospital Universitari General De Catalunya
Neurology, Carrer Pedro I Pons 1, 08195, Sant Cugat Del Valles
Hospital Clinic De Barcelona
Neurology, Calle Villarroel 170, 08036, Barcelona
Hospital Clinico San Carlos
Neurology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-02 | Netherlands | Acceptable 2026-02-09
|
2026-02-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-23 | Netherlands | Acceptable 2026-02-09
|
2026-02-23 |