NCT00412048

Brief Summary

The aim of the protocol is to study the resting brain activation profile of 3 groups of people, using a new fMRI procedure, called fMRI-SAM. fMRI-SAM will be applied to 25 Alzheimer's disease (AD) patients, 25 patients suffering from amnestic - mild cognitive impairment (MCI) - a clinical picture which may be a prodromal form of AD - and 60 healthy controls. The first analysis of the data will search differences of brain activation profiles between the 3 groups. In the second step, the investigators will study the predictive value of fMRI-SAM to detect MCI patients who will later convert to AD.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable

Status
withdrawn

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

December 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2006

Completed
5.3 years until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

June 8, 2026

Status Verified

November 1, 2012

Enrollment Period

5.8 years

First QC Date

December 14, 2006

Last Update Submit

June 5, 2026

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • Comparing fMRI data between 3 groups of subjects: MCI, Alzheimer's disease and normal subjects

    1, 5 years

Secondary Outcomes (1)

  • Follow-up of MCI patients at 6, 12 and 18 months to detect a conversion to Alzheimer's disease

    Prediction of Alzheimer's disease on fMRI data

Study Arms (3)

ALZHEIMER DISEASE

OTHER
Procedure: fMRI to detect MCI patients who will convert to Alzheimer's disease

MOLD COGNITIVE IMPAIRMENT

OTHER
Procedure: fMRI to detect MCI patients who will convert to Alzheimer's disease

CONTROLS

OTHER
Procedure: fMRI to detect MCI patients who will convert to Alzheimer's disease

Interventions

fMRI to detect MCI patients who will convert to Alzheimer's diseasePROCEDURE

There is a fMRI to be realized in the 3 arms. No drug is administered

ALZHEIMER DISEASECONTROLSMOLD COGNITIVE IMPAIRMENT

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Alzheimer's disease of mild to moderate severity (25 patients)
  • Amnestic MCI patients (25 patients)
  • year-old patients

You may not qualify if:

  • Any other cause of dementia for AD patients
  • Any stroke
  • Any disease with a negative vital prognosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Francois Sellal, MD

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2006

First Posted

December 15, 2006

Study Start

April 1, 2012

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

June 8, 2026

Record last verified: 2012-11