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

Primary Purpose

Alzheimer Disease, Battery

Status
Unknown status
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Memantine
Placebo
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer, Memantine, biomarkers, battery, cognition, imaging, neuropsychology

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • CHRU de Lille/ Centre d'investigation CliniqueRecruiting
  • CIC Marseille
  • CIC Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Memantine

Placebo

Arm Description

Memantine will be administered OS as of 10 mg- capsule one per day in the morning over 15 days.

The placebo will be presented as capsule comparable to memantine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 6, 2014
Last Updated
June 25, 2019
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT02288000
Brief Title
Prediction of Cognitive Properties of Memantine for Neurodegenerative Diseases
Acronym
WP3_P002
Official Title
Effect of a 15-day Memantine Treatment on Biomarkers of AD in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 14, 2016 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Battery
Keywords
Alzheimer, Memantine, biomarkers, battery, cognition, imaging, neuropsychology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Memantine
Arm Type
Active Comparator
Arm Description
Memantine will be administered OS as of 10 mg- capsule one per day in the morning over 15 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo will be presented as capsule comparable to memantine
Intervention Type
Drug
Intervention Name(s)
Memantine
Other Intervention Name(s)
Memantine Arrow
Intervention Description
Memantine will be administered OS as of 10 mg- capsule one per day in the morning over 15 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
the placebo will be administered OS as of 10 mg- capsule one per day in the morning over 15 days.
Primary Outcome Measure Information:
Title
Pharmacog battery
Description
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
Time Frame
15 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Régis Bordet, MD, PhD
Phone
+33 (0)3 20 44 54 49
Ext
+33
Email
regis.bordet@univ-lille2.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Régis Bordet, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Study Chair
Facility Information:
Facility Name
CHRU de Lille/ Centre d'investigation Clinique
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique Deplanque, PH
Email
dominique.deplanque@chru-lille.fr
First Name & Middle Initial & Last Name & Degree
Régis Bordet, MD PhD
Facility Name
CIC Marseille
City
Marseille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Blin
Email
olivier.blin@ap-hm.fr
Facility Name
CIC Toulouse
City
Toulouse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Rascol
Email
cic9302@purpan.inserm.fr

12. IPD Sharing Statement

Learn more about this trial

Prediction of Cognitive Properties of Memantine for Neurodegenerative Diseases

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