Can the Assessment of the Subhippocampal Region Contribute to the Detection of Early Diagnosis of Alzheimer's Disease? A Validation Study Using PET With Florbetapir (AV-45).
|ClinicalTrials.gov Identifier: NCT01746706|
Recruitment Status : Active, not recruiting
First Posted : December 11, 2012
Last Update Posted : April 14, 2017
Reliable diagnosis of Alzheimer's Disease (AD) at the predementia stage is currently considered to be a priority for research, as disease modifying therapies are being evaluated. Many studies focus on the functional and morphological assessment of the hippocampal formation. However, neurofibrillary tangles, associated with cognitive deficits, initially affect the anterior subhippocampal cortex (transentorhinal, entorhinal and perirhinal cortex) before reaching the hippocampus. Studies from our group have tried to investigate if the assessment of subhippocampal regions using cognitive tools and neuroimaging techniques could contribute to the diagnosis of AD at a very early stage.
In a previous project, the investigators included 40 patients with single domain amnestic MCI (Mild Cognitive Impairment), known to be at high risk for AD and demonstrated that aMCI patients with a profile of subhippocampal dysfunction (impaired performance on a visual recognition memory task) display other clinical as well as imaging profiles of patients with early AD using MRI and SPECT. Longitudinal follow-up data in these patients is currently under way. Preliminary data indicates that evaluating the subhippocampal region using visual recognition tasks is highly predictive of AD over 6 years.
The aim of this project is to obtain additional diagnostic data using a PET amyloid tracer (Florbetapir F18 AV45 F18), an in-vivo marker of one of the neuropathological lesions that define AD, of in order to enhance diagnostic accuracy AD in these patients. This approach will validate the hypothesis as to whether the assessment of subhippocampal dysfunction can contribute to the early diagnosis of AD.
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Device: PET amyloid tracer (Florbetapir F18 AV45 F18||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Can the Assessment of the Subhippocampal Region Contribute to the Detection of Early Diagnosis of Alzheimer's Disease?|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||November 2015|
|Estimated Study Completion Date :||November 2017|
|Experimental: patients||Device: PET amyloid tracer (Florbetapir F18 AV45 F18|
|Experimental: volunteers||Device: PET amyloid tracer (Florbetapir F18 AV45 F18|
- the assessment of subhippocampal dysfunction [ Time Frame: 24month ]PET amyloid tracer (Florbetapir F18 AV45 F18)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01746706
|Assistance Publique Hopitaux de Marseille|
|Marseille, France, 13354|
|Study Director:||BERNARD BELAIGUES||Assistance Publique Hopitaux De Marseille|
|Principal Investigator:||mira DIDIC||AP HM|