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Neuro Imaging and Multimodal Alzheimer's Disease (NIMAD)

Primary Purpose

Alzheimer Disease

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Neuroimaging

About this trial

This is an interventional basic science trial for Alzheimer Disease

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital of Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients with Alzheimer Disease

Controls patients

Arm Description

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

Controls will have neuroimaging by AV45-positron emission tomography

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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)

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))

Full Information

NCT ID

NCT02839187

First Posted

July 4, 2016

Last Updated

May 10, 2017

Sponsor

University Hospital, Toulouse

1. Study Identification

Unique Protocol Identification Number

NCT02839187

Brief Title

Neuro Imaging and Multimodal Alzheimer's Disease

Acronym

NIMAD

Official Title

Neuro Imaging and Multimodal Alzheimer's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

June 2010 (Actual)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients with Alzheimer Disease

Arm Type

Experimental

Arm Description

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

Arm Title

Controls patients

Arm Type

Active Comparator

Arm Description

Controls will have neuroimaging by AV45-positron emission tomography

Intervention Type

Radiation

Intervention Name(s)

Neuroimaging

Intervention Description

AV45-positron emission tomography

Primary Outcome Measure Information:

Title

fixing the AV-45 during PET

Description

Time Frame

baseline

Secondary Outcome Measure Information:

Title

Deposition of amyloid protein

Description

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

Time Frame

baseline

Title

Standard Cognitive function

Description

Time Frame

Baseline

Title

Specific memory evaluation

Description

anterograde verbal memory (test Gröber and Buschke), memory unique items (visual DMS48), semantic memory (sub-test information of theWechsler Adult Intelligence Scale (WAIS))

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

PARIENTE Jérémie, MD PhD

Organizational Affiliation

University Hospital, Toulouse

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital of Toulouse

City

Toulouse

ZIP/Postal Code

31000

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24573658

Citation

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.

Results Reference

result

PubMed Identifier

24435769

Citation

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.

Results Reference

result

PubMed Identifier

23731789

Citation

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.

Results Reference

result

Learn more about this trial

Neuro Imaging and Multimodal Alzheimer's Disease

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