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

June 25, 2019 updated by: University Hospital, Lille

Effect of a 15-day Memantine Treatment on Biomarkers of AD in Healthy Volunteers

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Memantine
Memantine will be administered OS as of 10 mg- capsule one per day in the morning over 15 days.
Drug: Memantine
Memantine will be administered OS as of 10 mg- capsule one per day in the morning over 15 days.
Other Names:
  • Memantine Arrow
Placebo Comparator: Placebo
The placebo will be presented as capsule comparable to memantine
Drug: Placebo
the placebo will be administered OS as of 10 mg- capsule one per day in the morning over 15 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacog battery
Time Frame: 15 days

  • cognitive tests (8 items of the Cantab battery) :

    • Motor screening
    • 4 tests for visual memory (Delayed Matching to Sample, Paired Associated Learning, Pattern Recognition Memory, Spatial Recognition Memory)
    • 1 test for executive functions (Spatial Working Memory)
    • 2 tests for attention (Reaction Time, Rapid Visual Information Processing)
    • completed by a modified ADNI battery : ADAScog

  • imaging

    • fMRI
    • PET-FDG

  • neurophysiological

    • EEG
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Study Chair: Régis Bordet, MD, PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2016

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

November 6, 2014

First Submitted That Met QC Criteria

November 6, 2014

First Posted (Estimate)

November 11, 2014

Study Record Updates

Last Update Posted (Actual)

June 27, 2019

Last Update Submitted That Met QC Criteria

June 25, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012_55
  • 2013-001671-21 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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