Prediction of Cognitive Properties of Memantine for Neurodegenerative Diseases

Alzheimer Disease Clinical Trial

— WP3_P002  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02288000
• Other study ID #: 2012_55
• Secondary ID: 2013-001671-21
• Status: Recruiting
• Phase: Phase 1
• Start date: September 14, 2016
• Est. completion date: September 2020

Study information

• Verified date: June 2019
• Source: University Hospital, Lille
• Contact: Régis Bordet, MD, PhD
• Phone: +33 (0)3 20 44 54 49
• Email: regis.bordet[@]univ-lille2.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Battery
• Neurodegenerative Diseases

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
France	CHRU de Lille/ Centre d'investigation Clinique	Lille
France	CIC Marseille	Marseille
France	CIC Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacog battery	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