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NIMAD: Neuro Imaging and Multimodal Alzheimer's Disease

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Completed
CT.gov ID
NCT02839187
Collaborator
(none)
59
Enrollment
1
Location
2
Arms
23
Actual Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The present study aimed at measuring cerebral changes in Alzheimer Disease (AD) patients, who responded to strict physiological criteria typical of AD pathology. The objective of the present study was to identify the earliest alterations in cerebral connections that could contribute to the initial episodic memory impairment.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Neuroimaging
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
59 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Neuro Imaging and Multimodal Alzheimer's Disease
Actual Study Start Date :
Jun 1, 2010
Actual Primary Completion Date :
May 1, 2012
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients with Alzheimer Disease

Patients will have Neuroimaging by Florbetapir (AV-45)-positron emission tomography

Radiation: Neuroimaging
AV45-positron emission tomography
Active Comparator: Controls patients

Controls will have neuroimaging by AV45-positron emission tomography

Radiation: Neuroimaging
AV45-positron emission tomography

Outcome Measures

Primary Outcome Measures

  1. fixing the AV-45 during PET [baseline]

    compare fixing the AV-45 during a examination emission tomography (PET) between three different groups: healthy subjects, patients with Alzheimer's disease and a mild stage patients of Alzheimer's disease at a pre-dementia stage

Secondary Outcome Measures

  1. Deposition of amyloid protein [baseline]

    Correlation between the deposition of amyloid protein assessed by metabolic imaging (AV-45) and cognitive performance in a group of patients with Alzheimer's disease compared to a control group

  2. Standard Cognitive function [Baseline]

    no memory performance: language (OD 80), executive functions (TMT A and B, evocations formal and categorical lexical, Stroop test, Pyramid-palm tree test Visual and Verbal) praxis visuo-constructive (copy of the figure of Rey) ; working memory (span of front and back numbers, subtest of the WAIS code-III)

  3. Specific memory evaluation [Baseline]

    anterograde verbal memory (test Gröber and Buschke), memory unique items (visual DMS48), semantic memory (sub-test information of theWechsler Adult Intelligence Scale (WAIS))

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
For all subjects :

  • Capacities visual, auditory (authorized devices) and oral or written expression sufficient for the proper performance of tests

  • Obtain informed written consent of the subject

Patients with AD :

  • Outpatient accompanied by a "helping"

  • No parenchymal lesions allowing isolation explain the symptoms on brain MRI (T1 and T2) carried more than 6 months prior to enrollment in the study. Patients with more than three hyperintense white matter or visible lacunar infarction or T2 FLAIR will not be included in the study.

  • probable Alzheimer's disease diagnosis par with international standards

  • Illness in a mild stage (CDR 1, 24 ≥ Mini-Mental State Examination (MMSE)> 18)

  • activity of daily living (ADL) 4 items> 1/4

Patients with Alzheimer's disease at a pre-dementia stage:

  • Alzheimer's Diagnosis pre-dementia based on the search criteria

  • Illness in a mild stage (CDR 0.5, 30 ≥ MMSE ≥ 25)

  • ADL items ≤ 4 1/4

Control subjects :

  • 30 ≥ MMSE ≥ 27

  • perfect autonomy in daily living (IADL = 0, CDR = 0)

  • Neuropsychological evaluation not highlighting of impaired cognitive performance with focus on memory performance

  • No parenchymal lesions on brain MRI.

  • Lack of family history (first degree) of Alzheimer's disease

Exclusion Criteria:

  • Subjects with a contra-indication to MRI (carrying a pacemaker or cardiac defibrillator, implanted a material activated by an electrical, magnetic or mechanical carriers hemostatic clips intracerebral aneurysms or carotid artery , holders of orthopedic implants, claustrophobia)

  • Subjects with clinically significant gastrointestinal, renal, hepatic, endocrine, or cardiovascular

  • Subjects with a psychiatric disorder or progressive neurological

  • French Language level insufficient to be appropriately involved in neurophysiological evaluation

  • less than 5 years Education (insufficient understanding level to participate in the study)

  • Administrative problems: unable to give informed about information, not covered by a social security system

  • Hypersensitivity to the active substance or to any of the excipients

  • unbalanced diabetes mellitus

  • Subjects treated by a non-steroidal anti-inflammatory

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital of Toulouse Toulouse France 31000

Sponsors and Collaborators

  • University Hospital, Toulouse

Investigators

  • Principal Investigator: PARIENTE Jérémie, MD PhD, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT02839187
Other Study ID Numbers:
  • 07 306 02
First Posted:
Jul 20, 2016
Last Update Posted:
May 11, 2017
Last Verified:
May 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Alzheimer Disease

Study Results

No Results Posted as of May 11, 2017