Neuro Imaging and Multimodal Alzheimer's Disease

NCT02839187 | Completed

• 1 other identifier: 07 306 02
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Deposition of amyloid protein

  baseline

• Standard Cognitive function

  Baseline

• Specific memory evaluation

  Baseline

Study Arms (2)

Patients with Alzheimer Disease

EXPERIMENTAL

Patients will have Neuroimaging by Florbetapir (AV-45)-positron emission tomography

Radiation: Neuroimaging

Controls patients

ACTIVE COMPARATOR

Controls will have neuroimaging by AV45-positron emission tomography

Radiation: Neuroimaging

Interventions

Neuroimaging RADIATION

AV45-positron emission tomography

Controls patients; Patients with Alzheimer Disease

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 :
• ≥ MMSE ≥ 27

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital of Toulouse

Toulouse, 31000, France

Location

Related Publications (3)

• 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.

  PMID: 24573658 RESULT

• 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.

  PMID: 24435769 RESULT

• 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.

  PMID: 23731789 RESULT

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Neuroimaging

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• PARIENTE Jérémie, MD PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2016
• First Posted: July 20, 2016
• Study Start: June 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 11, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)