Prediction of Cognitive Properties of Memantine for Neurodegenerative Diseases (WP3_P002)

University Hospital, Lille

Status and phase: Unknown; Phase 1

Conditions: Battery; Alzheimer Disease

Treatments: Drug: Placebo; Drug: Memantine

Study type: Interventional

Funder types: Other

Identifiers

NCT02288000

2013-001671-21 (EudraCT Number)

2012_55

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18-30 year old male non-smoker subjects
• 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 dementia or cognitive decline identified by Moca < 26
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Memantine

Active Comparator group

Description:

Memantine will be administered OS as of 10 mg- capsule one per day in the morning over 15 days.

Treatment:

Drug: Memantine

Placebo

Placebo Comparator group

Description:

The placebo will be presented as capsule comparable to memantine

Treatment:

Drug: Placebo