We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neuro Imaging and Multimodal Alzheimer's Disease (NIMAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02839187
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Radiation: Neuroimaging Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Neuro Imaging and Multimodal Alzheimer's Disease
Actual Study Start Date : June 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. fixing the AV-45 during PET [ Time Frame: 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 :
  1. Deposition of amyloid protein [ Time Frame: 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

  2. Standard Cognitive function [ Time Frame: 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)

  3. Specific memory evaluation [ Time Frame: Baseline ]
    anterograde verbal memory (test Gröber and Buschke), memory unique items (visual DMS48), semantic memory (sub-test information of theWechsler Adult Intelligence Scale (WAIS))


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02839187


Locations
Layout table for location information
France
University Hospital of Toulouse
Toulouse, France, 31000
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Layout table for investigator information
Principal Investigator: PARIENTE Jérémie, MD PhD University Hospital, Toulouse
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02839187    
Other Study ID Numbers: 07 306 02
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders