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