Trials / Completed
CompletedNCT04079803
PTI-125 for Mild-to-moderate Alzheimer's Disease Patients
A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multiple Dose, Biomarker and Safety Study of PTI-125 in Mild-to-moderate Alzheimer's Disease Patients
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 64 (actual)
- Sponsor
- Cassava Sciences, Inc. · Industry
- Sex
- All
- Age
- 50 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 2b, Randomized, Double-blind, Placebo-controlled, multiple dose study of PTI-125 in mild-to-moderate Alzheimer's disease patients.
Detailed description
This is a Phase 2b, Randomized, Double-blind, Placebo-controlled, multiple dose study of PTI-125 in mild-to-moderate Alzheimer's disease patients. A total of sixty (60) patients will be enrolled in the study. Patients will receive Placebo, 50 mg or 100 mg b.i.d. of PTI-125. The objective of this study are to investigate the safety, and biomarkers of PTI-125 following 28-day repeat oral administration.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo oral tablet | Oral placebo tablet |
| DRUG | Simufilam 100 mg tablet | Simufilam 100 mg oral tablet |
| DRUG | Simufilam 50 mg oral tablet | Simufilam 50 mg oral tablet |
Timeline
- Start date
- 2019-09-09
- Primary completion
- 2020-03-31
- Completion
- 2020-03-31
- First posted
- 2019-09-06
- Last updated
- 2021-09-29
- Results posted
- 2021-06-01
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04079803. Inclusion in this directory is not an endorsement.