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Neuro Imaging and Multimodal Alzheimer's Disease (NIMAD)

T

Toulouse University Hospital

Status

Completed

Conditions

Alzheimer Disease

Treatments

Radiation: Neuroimaging

Study type

Interventional

Funder types

Other

Identifiers

NCT02839187
07 306 02

Details and patient eligibility

About

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.

Enrollment

59 patients

Sex

All

Ages

60 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

59 participants in 2 patient groups

Patients with Alzheimer Disease
Experimental group
Description:
Patients will have Neuroimaging by Florbetapir (AV-45)-positron emission tomography
Treatment:
Radiation: Neuroimaging
Controls patients
Active Comparator group
Description:
Controls will have neuroimaging by AV45-positron emission tomography
Treatment:
Radiation: Neuroimaging

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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