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Clinical Trials/NCT02839187
NCT02839187
Completed
Not Applicable

Neuro Imaging and Multimodal Alzheimer's Disease

University Hospital, Toulouse1 site in 1 country59 target enrollmentJune 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
University Hospital, Toulouse
Enrollment
59
Locations
1
Primary Endpoint
fixing the AV-45 during PET
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
May 2012
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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:

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

Outcomes

Primary Outcomes

fixing the AV-45 during PET

Time Frame: 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 Outcomes

  • Deposition of amyloid protein(baseline)
  • Standard Cognitive function(Baseline)
  • Specific memory evaluation(Baseline)

Study Sites (1)

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