Trials / Completed
CompletedNCT00880412
A Study to Determine the Clinical Safety/Tolerability and Exploratory Efficacy of EHT 0202 as Adjunctive Therapy to Acetylcholinesterase Inhibitor in Mild to Moderate Alzheimer's Disease
A Pilot, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase IIA Study to Determine the Clinical Safety/Tolerability and Exploratory Efficacy of EHT 0202 (40 and 80 mg Bid) as Adjunctive Therapy to Acetylcholinesterase Inhibitor Over a 3-month Period in Ambulatory Patients Suffering From Mild to Moderate Alzheimer's Disease (EHT 0202/002 Protocol)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 197 (actual)
- Sponsor
- Exonhit · Industry
- Sex
- All
- Age
- 60 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this 3-month study is to assess the safety and efficacy of EHT 0202 in addition to acetylcholinesterase inhibitor in patients suffering from Alzheimer's Disease.
Detailed description
The aim of this pilot study is to assess the safety and tolerability profile of 2 doses of EHT 0202 (40 mg and 80 mg b.i.d) versus placebo in addition to a treatment with acetylcholinesterase inhibitor and its exploratory efficacy on cognition, behavior, activities of daily living, caregiver's burden and patient's global assessment, during a 3-month treatment period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | EHT 0202 etazolate | In each arm, 2 capsules of study treatment (capsules of EHT0202 40mg and/or placebo) are taken twice a day during breakfast and dinner over a 3-month treatment period. There is non treatment adjustment. |
| DRUG | Placebo | In each arm, 2 capsules of study treatment (capsules of EHT0202 40mg and/or placebo) are taken twice a day during breakfast and dinner over a 3-month treatment period. There is non treatment adjustment. |
Timeline
- Start date
- 2008-04-01
- Primary completion
- 2009-06-01
- Completion
- 2009-08-01
- First posted
- 2009-04-13
- Last updated
- 2009-09-21
Locations
22 sites across 1 country: France
Source: ClinicalTrials.gov record NCT00880412. Inclusion in this directory is not an endorsement.