Prediction of Cognitive Properties of Memantine for Neurodegenerative Diseases
NCT ID: NCT02288000
Last Updated: 2019-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
30 participants
INTERVENTIONAL
2016-09-14
2020-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Memantine
Memantine will be administered OS as of 10 mg- capsule one per day in the morning over 15 days.
Memantine
Memantine will be administered OS as of 10 mg- capsule one per day in the morning over 15 days.
Placebo
The placebo will be presented as capsule comparable to memantine
Placebo
the placebo will be administered OS as of 10 mg- capsule one per day in the morning over 15 days.
Interventions
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Memantine
Memantine will be administered OS as of 10 mg- capsule one per day in the morning over 15 days.
Placebo
the placebo will be administered OS as of 10 mg- capsule one per day in the morning over 15 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject without cognitive impairment or cognitive complaint (Moca\>26, Mac Nair scale\<15)
* Subject without history of brain disease (severe brain trauma, stroke, cerebral tumor,…)
* Subject without major medical or surgical history
* Subject without current chronic disease
* Subject without current cerebral disease
* Subject without vascular or metabolic risk factor
* Subject without history or current mental disease or addiction (MINI)
* Subject without lesion on MRI
* Subject without abnormal electrical activities on EEG
* Subject without use of chronic treatment or psychotropic drugs or substances
* French speaker subject and able to understand the test instructions
Exclusion Criteria
* Subject with vascular or metabolic risk factor
* Subject with history or current mental disease or addiction
* Subject with family history of young-onset dementia
* Subject with family history of chronic or severe neurological or mental disease (first degree relatives)
* Subject receiving a chronic treatment
* Subject with claustrophobia or contra-indication to MRI
* Subject unable to understand the test instructions
18 Years
30 Years
MALE
Yes
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Régis Bordet, MD, PhD
Role: STUDY_CHAIR
University Hospital, Lille
Locations
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CHRU de Lille/ Centre d'investigation Clinique
Lille, , France
CIC Marseille
Marseille, , France
CIC Toulouse
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2013-001671-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2012_55
Identifier Type: -
Identifier Source: org_study_id
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