Neuro Imaging and Multimodal Alzheimer's Disease

Not Applicable

Completed

• Conditions: Alzheimer Disease
• Interventions: Radiation: Neuroimaging

• Registration Number: NCT02839187
• Lead Sponsor: University Hospital, Toulouse

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Study First Submitted: 2016-07-04
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-20
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-10
• Last Update Posted: 2017-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Controls patients	Neuroimaging	Controls will have neuroimaging by AV45-positron emission tomography
Patients with Alzheimer Disease	Neuroimaging	Patients will have Neuroimaging by Florbetapir (AV-45)-positron emission tomography

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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)
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))

Trial Locations

Locations (1)

University Hospital of Toulouse; 🇫🇷 Toulouse, France