Clinical trial • Phase I • Neurology

DNL628 for Early Alzheimer's disease | Alzheimer's disease

Phase I trial of DNL628 for Early Alzheimer's disease | Alzheimer's disease. 41 participants.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Early Alzheimer's disease | Alzheimer's disease
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
13-10-2025
First CTIS Authorization Date
18-02-2026

Trial design

Phase I trial across 3 sites in Netherlands.

Target Sample Size
41

Eligibility

Recruits 41 Vulnerable population not selected; no consent/assent handling described..

Vulnerable Population
Vulnerable population not selected; no consent/assent handling described.

Recruitment

Planned Sample Size
41
Recruitment Window Months
37

Geography

Total Number Of Sites
3
Total Number Of Participants
27

Netherlands

Earliest CTIS Part Ii Submission Date
12-02-2026
Latest Decision Or Authorization Date
18-02-2026
Processing Time Days
6
Number Of Sites
3
Number Of Participants
27

Sites

Site Name
Brain Research Center Amsterdam B.V.
Department Name
Neurology
Contact Person Name
E.G.B. Vijverberg
Site Name
Brain Research Center Den Bosch B.V.
Department Name
Neurology
Contact Person Name
E.G.B. Vijverberg
Site Name
Brain Research Center Zwolle B.V.
Department Name
Neurology
Contact Person Name
E.G.B. Vijverberg

Sponsor

Primary sponsor

Full Name
Denali Therapeutics Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
DNL628

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