Prediction of Cognitive Properties of Memantine for Neurodegenerative Diseases

Last updated: June 25, 2019
Sponsor: University Hospital, Lille
Overall Status: Active - Recruiting

Phase

1

Condition

Multiple Sclerosis

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT02288000
2012_55
2013-001671-21
  • Ages 18-30
  • Male
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18-30 year old male non-smoker subjects

  • Subject without cognitive impairment or cognitive complaint (Moca>26, Mac Nairscale<15)

  • Subject without history of brain disease (severe brain trauma, stroke, cerebraltumor,…)

  • 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

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 (firstdegree relatives)

  • Subject receiving a chronic treatment

  • Subject with claustrophobia or contra-indication to MRI

  • Subject unable to understand the test instructions

Study Design

Total Participants: 30
Study Start date:
September 14, 2016
Estimated Completion Date:
September 30, 2020

Study 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

Connect with a study center

  • CHRU de Lille/ Centre d'investigation Clinique

    Lille, 59037
    France

    Active - Recruiting

  • CIC Marseille

    Marseille,
    France

    Site Not Available

  • CIC Toulouse

    Toulouse,
    France

    Site Not Available

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