Neuro Imaging and Multimodal Alzheimer's Disease (NIMAD)

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Radiation: Neuroimaging

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31000
    • University Hospital of Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fixing the AV-45 during PET	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	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Deposition of amyloid protein	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	baseline
Standard Cognitive function	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)	Baseline
Specific memory evaluation	anterograde verbal memory (test Gröber and Buschke), memory unique items (visual DMS48), semantic memory (sub-test information of theWechsler Adult Intelligence Scale (WAIS))	Baseline

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2010
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: July 4, 2016
• First Submitted That Met QC Criteria: July 18, 2016
• First Posted (Estimate): July 20, 2016

Study Record Updates

• Last Update Posted (Actual): May 11, 2017
• Last Update Submitted That Met QC Criteria: May 10, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 07 306 02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No