Neuro Imaging and Multimodal Alzheimer's Disease

Alzheimer Disease Clinical Trial

— NIMAD  

Official title:

Neuro Imaging and Multimodal Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02839187
• Other study ID #: 07 306 02
• Status: Completed
• Phase: N/A
• First received: July 4, 2016
• Last updated: May 10, 2017
• Start date: June 2010
• Est. completion date: May 2012

Study information

• Verified date: May 2017
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Radiation:
• Neuroimaging
AV45-positron emission tomography

Locations

Country	Name	City	State
France	University Hospital of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (3)

Nemmi F, Saint-Aubert L, Adel D, Salabert AS, Pariente J, Barbeau EJ, Payoux P, Péran 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 Imag — View Citation

Saint-Aubert L, Barbeau EJ, Péran 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 pat — View Citation

Saint-Aubert L, Nemmi F, Péran 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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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