Treeway B.V.
This is a multi-center, Phase IIa, randomized, double-blind, placebo-controlled study in patients with Alzheimer's Disease (AD).
Alzheimer Disease
TW001
Placebo
Phase 2
This is an exploratory, double-blind, randomized, placebo-controlled phase IIa proof of concept study to evaluate the safety, pharmacodynamics and pharmacokinetics of TW001 in patients with mild AD. Patients will be randomized 1:1 to TW001 and placebo. Treatments will be given in a fasted state once daily for 90 days. The total duration of the clinical trial will be approximately 4 months per patient.
Study Type : | Interventional |
Estimated Enrollment : | 60 participants |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of TW001 in Alzheimer Patients |
Actual Study Start Date : | March 1, 2023 |
Estimated Primary Completion Date : | January 2024 |
Estimated Study Completion Date : | June 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: TW001 |
Drug: TW001 |
Placebo Comparator: Placebo |
Drug: Placebo |
Ages Eligible for Study: | 55 Years to 80 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
University Hospital Centre Osijek
Osijek, Croatia, 31000
Recruiting
University Hospital Centre Zagreb
Zagreb, Croatia, 10000
Recruiting
Brain Research Center Amsterdam
Amsterdam, Netherlands, 1081 GN
Recruiting
Brain Research Center Den Bosch
Den Bosch, Netherlands, 5223 LA
Recruiting
ETZ Elisabeth ziekenhuis
Tilburg, Netherlands, 5022 GC
Recruiting
Brain Research Center Zwolle
Zwolle, Netherlands, 8025 AZ