Clinical trial NCT02839187: Neuro Imaging and Multimodal Alzheimer's Disease
Official title: Neuro Imaging and Multimodal Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 59
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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:

* 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

Primary outcomes:
measure: fixing the AV-45 during PET
timeFrame: baseline
Secondary outcomes:
measure: Deposition of amyloid protein
timeFrame: baseline
measure: Standard Cognitive function
timeFrame: Baseline
measure: Specific memory evaluation
timeFrame: Baseline
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: PARIENTE Jérémie, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nemmi F, Saint-Aubert L, Adel D, Salabert AS, Pariente J, Barbeau EJ, Payoux P, Peran P. Insight on AV-45 binding in white and grey matter from histogram analysis: a study on early Alzheimer's disease patients and healthy subjects. Eur J Nucl Med Mol Imaging. 2014 Jul;41(7):1408-18. doi: 10.1007/s00259-014-2728-4. Epub 2014 Feb 27.
citation: Saint-Aubert L, Nemmi F, Peran P, Barbeau EJ, Payoux P, Chollet F, Pariente J. Comparison between PET template-based method and MRI-based method for cortical quantification of florbetapir (AV-45) uptake in vivo. Eur J Nucl Med Mol Imaging. 2014 May;41(5):836-43. doi: 10.1007/s00259-013-2656-8. Epub 2013 Dec 19.
citation: Saint-Aubert L, Barbeau EJ, Peran P, Nemmi F, Vervueren C, Mirabel H, Payoux P, Hitzel A, Bonneville F, Gramada R, Tafani M, Vincent C, Puel M, Dechaumont S, Chollet F, Pariente J. Cortical florbetapir-PET amyloid load in prodromal Alzheimer's disease patients. EJNMMI Res. 2013 Jun 3;3(1):43. doi: 10.1186/2191-219X-3-43.