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Prediction of Cognitive Properties of Memantine for Neurodegenerative Diseases

Information source: University Hospital, Lille
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alzheimer Disease; Battery

Intervention: Memantine (Drug); Placebo (Drug)

Phase: Phase 1

Status: Not yet recruiting

Sponsored by: University Hospital, Lille

Official(s) and/or principal investigator(s):
Régis Bordet, MD, PhD, Study Chair, Affiliation: University Hospital, Lille

Overall contact:
Régis Bordet, MD, PhD, Email: regis.bordet@univ-lille2.fr


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Pharmacog battery

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


Minimum age: 18 Years. Maximum age: 30 Years. Gender(s): Male.


Inclusion Criteria:

- 18-30 year old male non-smoker subjects

- Subject without cognitive impairment or cognitive complaint (Moca>26, Mac Nair


- Subject without history of brain disease (severe brain trauma, stroke, cerebral


- 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

Locations and Contacts

Régis Bordet, MD, PhD, Email: regis.bordet@univ-lille2.fr

Centre d'Investigation Clinique - CHRU de Lille, Lille 59000, France

CHRU de Lille/ Centre d'investigation Clinique, Lille 59037, France

CIC Marseille, Marseille, France; Not yet recruiting
Olivier Blin, Email: olivier.blin@ap-hm.fr

CIC Toulouse, Toulouse, France; Not yet recruiting
Olivier Rascol, Email: cic9302@purpan.inserm.fr

Additional Information

Starting date: August 2015
Last updated: June 17, 2015

Page last updated: August 23, 2015

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