NCT02288000

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for phase_1 alzheimer-disease

Timeline
Completed

Started Sep 2016

Longer than P75 for phase_1 alzheimer-disease

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 11, 2014

Completed
1.8 years until next milestone

Study Start

First participant enrolled

September 14, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

4.3 years

First QC Date

November 6, 2014

Last Update Submit

April 29, 2026

Conditions

Alzheimer DiseaseBattery

Keywords

AlzheimerMemantinebiomarkersbatterycognitionimagingneuropsychology

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Memantine

ACTIVE COMPARATOR

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

Drug: Memantine

Placebo

PLACEBO COMPARATOR

The placebo will be presented as capsule comparable to memantine

Drug: Placebo

Interventions

MemantineDRUG

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

Also known as: Memantine Arrow
Memantine
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHRU de Lille/ Centre d'investigation Clinique

Lille, 59037, France

Location

CIC Marseille

Marseille, France

Location

CIC Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Memantine

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Régis Bordet, MD, PhD

    University Hospital, Lille

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2014

First Posted

November 11, 2014

Study Start

September 14, 2016

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations

FR(3)