Trials / Unknown
UnknownNCT02288000
Prediction of Cognitive Properties of Memantine for Neurodegenerative Diseases
Effect of a 15-day Memantine Treatment on Biomarkers of AD in Healthy Volunteers
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- University Hospital, Lille · Academic / Other
- Sex
- Male
- Age
- 18 Years – 30 Years
- Healthy volunteers
- Accepted
Summary
The early assessment of new drugs for Alzheimer's disease remains difficult because of the lack of predictive end-point. The use of a battery including different parameters could improve this early development of new drugs. Nevertheless, the interest of such a battery should previously be validated with the yet marketed AD drugs.
Detailed description
The aim of the present study is to test the effect of a 15-day treatment with memantine on a mixed battery associating cognitive assessment, imaging and neurophysiological tests in healthy volunteers. This multicenter, randomized, placebo-controlled, cross-over study is double-blind controlled and is conducted in 3 centers located in France (Lille, Marseille and Toulouse). 18-30 years old, healthy volunteers, without any neurological or psychiatric impairment, will complete 2 test sessions in a randomized order: one with a 15-day treatment with memantine, the other with placebo, and will be submitted to a mixed battery during the 14th and 15th day of the treatment. The primary outcome of the study will be based on cognitive assessment, imaging parameters and neurophysiological parameters
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Memantine | Memantine will be administered OS as of 10 mg- capsule one per day in the morning over 15 days. |
| DRUG | Placebo | the placebo will be administered OS as of 10 mg- capsule one per day in the morning over 15 days. |
Timeline
- Start date
- 2016-09-14
- Primary completion
- 2020-09-01
- Completion
- 2020-09-01
- First posted
- 2014-11-11
- Last updated
- 2019-06-27
Locations
3 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02288000. Inclusion in this directory is not an endorsement.