Trials / Completed
CompletedNCT02079909
Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease (US202)
A Phase 2 Multi-center, Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 482 (actual)
- Sponsor
- FUJIFILM Toyama Chemical Co., Ltd. · Industry
- Sex
- All
- Age
- 55 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective is to evaluate the efficacy of T-817MA as measured by ADAS-cog and ADCS-CGIC. The secondary objectives are: * To evaluate the safety and tolerability of T-817MA measured by clinical safety laboratories, physical examinations, ECGs and solicitation of adverse events. * To evaluate the efficacy of T-817MA as measured by ADCS-ADL, FAQ, Neuropsychiatric Inventory (NPI) and Mini-mental State Examination (MMSE).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | T-817MA-H | 224 mg or 448 mg T-817 MA once daily |
| DRUG | T-817MA-L | 224 mg T-817 MA once daily |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2017-05-05
- Completion
- 2017-05-05
- First posted
- 2014-03-06
- Last updated
- 2019-02-26
- Results posted
- 2018-08-09
Locations
50 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02079909. Inclusion in this directory is not an endorsement.