Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
68
Countries
1
Sites
3
Early Alzheimer's Disease
Key facts
- Sponsor
- Denali Therapeutics 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
- 3 Apr 2026 → ongoing
- Decision date (initial)
- 2026-02-18
- 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
Early 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
Denali Therapeutics Inc.
- Sponsor organisation
- Denali Therapeutics Inc.
- Address
- 161 Oyster Point Boulevard
- City
- South San Francisco
- Postcode
- 94080-2042
- Country
- United States
Scientific contact point
- Organisation
- Denali Therapeutics Inc.
- Contact name
- Richard Tsai, MD
Public contact point
- Organisation
- Denali Therapeutics Inc.
- Contact name
- Clinical Trials Group
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 27 | 3 |
| Rest of world
United Kingdom
|
— | 41 | — |
Investigational sites
Brain Research Center Den Bosch B.V.
Neurology, Statenlaan 37, 5223 LA, 's-Hertogenbosch
Brain Research Center Amsterdam B.V.
Neurology, Cronenburg 2, 1081 GN, Amsterdam
Brain Research Center Zwolle B.V.
Neurology, Dokter Stolteweg 90, 8025 AZ, Zwolle
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 | 2026-04-03 | 2026-05-27 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-13 | Netherlands | Acceptable 2026-02-16
|
2026-02-18 |