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Multi-modal Neuroimaging in Alzheimer's Disease (IMAP)

Primary Purpose

Alzheimer's Disease

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

assessment of memory

circulating tPA dosage

ApoE4

Brain imaging examination MRI and PET examinations

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease focused on measuring Alzheimer's disease, MCI, genetic, AV45-PET

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Education level > 7 years
Native language: French
Medical, neurological, neuropsychological and neuroradiological depth in accordance with the criteria for inclusion and exclusion-specific population, that is to say:
- Healthy young controls: between 18 and 40 years old; normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.5 SD).
- Healthy Middle-aged controls: between 40 and 60 years old; without memory complaints, normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.5 SD).
- Healthy Elderly controls: over 60 years old, living at home, without memory complaints, normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.5 SD).
- MCI patients: over 60 years old, presenting the current criteria for amnestic MCI including: i) memory complaint, ii) deficits of the episodic memory (lower performance of at least 1.5 SD from the norm for age and cultural level for one or more scores of episodic memory and iii) normal performances compared to the age and the educational level of all other cognitive functions as memory, including tests to assess cognitive abilities.
- Alzheimer's patients: presenting the standard criteria of NINCDS-ADRDA probable Alzheimer's disease, including abnormal global cognitive function and deficits in at least two cognitive domains identified by the diagnostic battery and a mild to moderate Alzheimer's disease (MMSE ≥ 15).

Exclusion Criteria:

The sudden onset of cognitive impairments (as opposed to their slow and gradual installation in Alzheimer's disease)
A chronic neurological, psychiatric, endocrine, hepatic or infectious complaint
A history of major disease (an uncontrolled diabetes, a lung, heart, metabolic, hematologic, endocrine disease or a severe cancer);
A medication that may interfere with memory or metabolic measures
A alcohol or drugs abuse
claustrophobia, metallic object in the body
A predominantly left-hand (score below 50% in Edinburgh Inventory).
Protected adults, and persons not affiliated with a social security system will not participate in this study.
The inclusion of a participant in another biomedical research protocol (during the study or within 12 months before inclusion)

Sites / Locations

University Hospital Côte de Nacre
University Hospital Roger Salengro
University Hospital Pontchaillou
University Hospital Rouen
University Hospital Tours

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Arm Label

Young controls

Middle age controls

Elderly controls

Autosomal dominant forms of early-onset Alzheimer disease

Subjectif Cognitive Impariment patients

Mild Cognitive Impairment patients

Alzheimer Disease patients

Non degenerative amnsesic syndrome

Frontotemporal lobe dementia

Arm Description

Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.

Outcomes

Primary Outcome Measures

Rate of volume change of whole brain, hippocampus and other structural MRI measures

Rate of Decline as measured by: Cognitive Tests, Activities of Daily Living, and CDR Sum of Boxes

Rates of change on each specified biochemical biomarker

Rates of change of glucose metabolism (FDG-PET)

Extent of amyloid deposition as measured by 18F-AV45

Group differences for each imaging and biomarker measurement

APOE genotype

Secondary Outcome Measures

Full Information

NCT ID

NCT01554202

First Posted

March 13, 2012

Last Updated

March 5, 2013

Sponsor

University Hospital, Caen

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

1. Study Identification

Unique Protocol Identification Number

NCT01554202

Brief Title

Multi-modal Neuroimaging in Alzheimer's Disease

Acronym

IMAP

Official Title

Study of the Predictive Markers and the Pathophysiological Mechanisms of Alzheimer's Disease: Transverse and Longitudinal Approach in Anatomical and Functional Multimodal Imaging

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Unknown status

Study Start Date

January 2008 (undefined)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Caen

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

According to estimations, Alzheimer's disease affects approximately 860,000 people aged of more than 65 years in France. This disease is characterized by disorders of cognitive functions, including memory, associated with structural and functional modifications of the brain. These changes are evolving within the pathology progression and can be evaluated with neuropsychological tests (to assess capabilities such as language, orientation, etc.) and also with brain imaging (e.g. MRI). Alzheimer's disease is still poorly understood, nevertheless currently available treatments can slow its development if the disease is diagnosed early enough. Thus, the objective is to identify markers for early diagnosis of Alzheimer's disease, to better describe the evolution of this disease. The three main objectives of this project are to identify, compare and combine predictive markers of Alzheimer's disease to make a significant contribution to the understanding of the pathophysiological mechanisms of Alzheimer's disease to study the ability of different neuroimaging techniques to follow the evolution of this pathology.

6. Conditions and Keywords

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

Alzheimer's Disease

Keywords

Alzheimer's disease, MCI, genetic, AV45-PET

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

295 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Young controls

Arm Type

Experimental

Arm Description

Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.

Arm Title

Middle age controls

Arm Type

Experimental

Arm Description

Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.

Arm Title

Elderly controls

Arm Type

Experimental

Arm Description

Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.

Arm Title

Autosomal dominant forms of early-onset Alzheimer disease

Arm Type

Experimental

Arm Description

Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.

Arm Title

Subjectif Cognitive Impariment patients

Arm Type

Experimental

Arm Description

Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.

Arm Title

Mild Cognitive Impairment patients

Arm Type

Experimental

Arm Description

Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.

Arm Title

Alzheimer Disease patients

Arm Type

Experimental

Arm Description

Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.

Arm Title

Non degenerative amnsesic syndrome

Arm Type

Experimental

Arm Description

Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.

Arm Title

Frontotemporal lobe dementia

Arm Type

Experimental

Arm Description

Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.

Intervention Type

Behavioral

Intervention Name(s)

assessment of memory

Intervention Type

Biological

Intervention Name(s)

circulating tPA dosage

Intervention Type

Genetic

Intervention Name(s)

ApoE4

Intervention Type

Other

Intervention Name(s)

Brain imaging examination MRI and PET examinations

Primary Outcome Measure Information:

Title

Rate of volume change of whole brain, hippocampus and other structural MRI measures

Time Frame

3 years

Title

Rate of Decline as measured by: Cognitive Tests, Activities of Daily Living, and CDR Sum of Boxes

Time Frame

3 years

Title

Rates of change on each specified biochemical biomarker

Time Frame

3 years

Title

Rates of change of glucose metabolism (FDG-PET)

Time Frame

3 years

Title

Extent of amyloid deposition as measured by 18F-AV45

Time Frame

3 years

Title

Group differences for each imaging and biomarker measurement

Time Frame

3 years

Title

APOE genotype

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Education level > 7 years Native language: French Medical, neurological, neuropsychological and neuroradiological depth in accordance with the criteria for inclusion and exclusion-specific population, that is to say: Healthy young controls: between 18 and 40 years old; normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.5 SD). Healthy Middle-aged controls: between 40 and 60 years old; without memory complaints, normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.5 SD). Healthy Elderly controls: over 60 years old, living at home, without memory complaints, normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.5 SD). MCI patients: over 60 years old, presenting the current criteria for amnestic MCI including: i) memory complaint, ii) deficits of the episodic memory (lower performance of at least 1.5 SD from the norm for age and cultural level for one or more scores of episodic memory and iii) normal performances compared to the age and the educational level of all other cognitive functions as memory, including tests to assess cognitive abilities. Alzheimer's patients: presenting the standard criteria of NINCDS-ADRDA probable Alzheimer's disease, including abnormal global cognitive function and deficits in at least two cognitive domains identified by the diagnostic battery and a mild to moderate Alzheimer's disease (MMSE ≥ 15). Exclusion Criteria: The sudden onset of cognitive impairments (as opposed to their slow and gradual installation in Alzheimer's disease) A chronic neurological, psychiatric, endocrine, hepatic or infectious complaint A history of major disease (an uncontrolled diabetes, a lung, heart, metabolic, hematologic, endocrine disease or a severe cancer); A medication that may interfere with memory or metabolic measures A alcohol or drugs abuse claustrophobia, metallic object in the body A predominantly left-hand (score below 50% in Edinburgh Inventory). Protected adults, and persons not affiliated with a social security system will not participate in this study. The inclusion of a participant in another biomedical research protocol (during the study or within 12 months before inclusion)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vincent de La Sayette, MD

Organizational Affiliation

University Hospital, Caen

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Côte de Nacre

City

Caen

ZIP/Postal Code

14033

Country

France

Facility Name

University Hospital Roger Salengro

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

University Hospital Pontchaillou

City

Rennes

ZIP/Postal Code

35033

Country

France

Facility Name

University Hospital Rouen

City

Rouen

ZIP/Postal Code

76031

Country

France

Facility Name

University Hospital Tours

City

Tours

ZIP/Postal Code

37044

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

21382329

Citation

Chetelat G. [Neuroimaging Alzheimer's disease: early diagnosis, monitoring, and mechanism understanding]. Med Sci (Paris). 2011 Feb;27(2):193-8. doi: 10.1051/medsci/2011272193. Epub 2011 Mar 8. French.

Results Reference

background

PubMed Identifier

20226489

Citation

Mevel K, Grassiot B, Chetelat G, Defer G, Desgranges B, Eustache F. [The default mode network: cognitive role and pathological disturbances]. Rev Neurol (Paris). 2010 Nov;166(11):859-72. doi: 10.1016/j.neurol.2010.01.008. Epub 2010 Mar 11. French.

Results Reference

background

PubMed Identifier

20600996

Citation

La Joie R, Fouquet M, Mezenge F, Landeau B, Villain N, Mevel K, Pelerin A, Eustache F, Desgranges B, Chetelat G. Differential effect of age on hippocampal subfields assessed using a new high-resolution 3T MR sequence. Neuroimage. 2010 Nov 1;53(2):506-14. doi: 10.1016/j.neuroimage.2010.06.024. Epub 2010 Jun 16.

Results Reference

result

PubMed Identifier

20331499

Citation

Villain N, Landeau B, Groussard M, Mevel K, Fouquet M, Dayan J, Eustache F, Desgranges B, Chetelat G. A simple way to improve anatomical mapping of functional brain imaging. J Neuroimaging. 2010 Oct;20(4):324-33. doi: 10.1111/j.1552-6569.2010.00470.x.

Results Reference

result

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Multi-modal Neuroimaging in Alzheimer's Disease

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