Multi-modal Neuroimaging in Alzheimer's Disease IMAP+

NCT01638949 | Completed DMC

• 1 other identifier: 2011-A01493-38
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 7

Brief Summary

Alzheimer's disease (AD) is a major public health problem due to its socio-economic weight. An early diagnosis of AD is urgently needed as it would constitute a determinant breakthrough from a social, financial and research standpoints. Therefore, the investigators need predictive markers of AD, and neuroimaging is a particularly promising tool, especially when using complementary neuroimaging techniques and a longitudinal design, allowing to assess the relationships between the different biomarkers of the disease, their dynamic and their chronology.

Conditions

Alzheimer's Disease

Keywords

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

Outcome Measures

Primary Outcomes (7)

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

  3 years

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

  3 years

• Rates of change on each specified biochemical biomarker

  3 years

• Rates of change of glucose metabolism (FDG-PET)

  3 years

• Extent of amyloid deposition as measured by 18F-AV45

  3 years

• Group differences for each imaging and biomarker measurement

  3 years

• APOE genotype

  3 years

Study Arms (8)

Young controls

EXPERIMENTAL

Behavioral: Memory assessment; Biological: Circulating biomarkers measure; Genetic: ApoE4; Other: Brain imaging examination MRI and PET examinations

Middle age controls

EXPERIMENTAL

Behavioral: Memory assessment; Biological: Circulating biomarkers measure; Genetic: ApoE4; Other: Brain imaging examination MRI and PET examinations

Elderly controls

EXPERIMENTAL

Behavioral: Memory assessment; Biological: Circulating biomarkers measure; Genetic: ApoE4; Other: Brain imaging examination MRI and PET examinations

Asymptomatic subjects

EXPERIMENTAL

Asymptomatic subjects from families carrying a genetic mutation with an autosomal dominant transmission

Behavioral: Memory assessment; Biological: Circulating biomarkers measure; Genetic: ApoE4; Other: Brain imaging examination MRI and PET examinations

Subjectif Cognitive Impariment patients

EXPERIMENTAL

Behavioral: Memory assessment; Biological: Circulating biomarkers measure; Genetic: ApoE4; Other: Brain imaging examination MRI and PET examinations

Mild Cognitive Impairment patients

EXPERIMENTAL

Behavioral: Memory assessment; Biological: Circulating biomarkers measure; Genetic: ApoE4; Other: Brain imaging examination MRI and PET examinations

Alzheimer Disease patients

EXPERIMENTAL

Behavioral: Memory assessment; Biological: Circulating biomarkers measure; Genetic: ApoE4; Other: Brain imaging examination MRI and PET examinations

Non degenerative amnsesic syndrome

EXPERIMENTAL

Behavioral: Memory assessment; Biological: Circulating biomarkers measure; Genetic: ApoE4; Other: Brain imaging examination MRI and PET examinations

Interventions

Brain imaging examination MRI and PET examinations OTHER

Structural and functional MRI FDG-PET to compare differences between each populations.

Alzheimer Disease patients; Asymptomatic subjects; Elderly controls; Middle age controls; Mild Cognitive Impairment patients; Non degenerative amnsesic syndrome; Subjectif Cognitive Impariment patients; Young controls

Memory assessment BEHAVIORAL

Neuropsycological tests including clinical and original tests to compare differences between each populations.

Alzheimer Disease patients; Asymptomatic subjects; Elderly controls; Middle age controls; Mild Cognitive Impairment patients; Non degenerative amnsesic syndrome; Subjectif Cognitive Impariment patients; Young controls

Circulating biomarkers measure BIOLOGICAL

ELISA tests from blood samples to compare differences between each populations.

Alzheimer Disease patients; Asymptomatic subjects; Elderly controls; Middle age controls; Mild Cognitive Impairment patients; Non degenerative amnsesic syndrome; Subjectif Cognitive Impariment patients; Young controls

ApoE4 GENETIC

Evaluation of apolipoprotein E polymorphism as a risk factor.

Alzheimer Disease patients; Asymptomatic subjects; Elderly controls; Middle age controls; Mild Cognitive Impairment patients; Non degenerative amnsesic syndrome; Subjectif Cognitive Impariment patients; Young controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Education level \> 7 years
• Native language: French
• Healthy young volunteers: between 18 and 40 years old; normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.65 SD).
• Healthy Middle-aged volunteers: 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 (± 1.65 SD).
• Healthy Elderly volunteers: 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 (± 1.65 SD).
• SCI patients: over 60 years old ; memory complaints; memory complaint ; normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.65 SD).
• MCI patients: presenting the current criteria for amnestic MCI including: i) memory complaint, ii) deficits of the episodic memory (lower performance of at least 1.65 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).

You may not qualify if:

• 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
• The cons-indications to MRI (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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• University Hospital, Caen: lead

Study Sites (7)

GIP Cyceron

Caen, Calvados, 14000, France

Location

Inserm - EPHE - University of Caen U1077

Caen, 14000, France

Location

University Hospital Côte de Nacre

Caen, 14033, France

Location

University Hospital Roger Salengro

Lille, 59037, France

Location

University Hospital Pontchaillou

Rennes, 35033, France

Location

University Hospital Rouen

Rouen, 76031, France

Location

University Hospital Tours

Tours, 37044, France

Location

Related Publications (3)

• Kuhn E, Perrotin A, La Joie R, Touron E, Dautricourt S, Vanhoutte M, Vivien D, de La Sayette V, Chetelat G; Alzheimer's Disease Neuroimaging Initiative. Association of the Informant-Reported Memory Decline With Cognitive and Brain Deterioration Through the Alzheimer Clinical Continuum. Neurology. 2023 Jun 13;100(24):e2454-e2465. doi: 10.1212/WNL.0000000000207338. Epub 2023 Apr 21.

  PMID: 37085328 RESULT

• Kuhn E, Moulinet I, Perrotin A, La Joie R, Landeau B, Tomadesso C, Bejanin A, Sherif S, De La Sayette V, Desgranges B, Vivien D, Poisnel G, Chetelat G. Cross-sectional and longitudinal characterization of SCD patients recruited from the community versus from a memory clinic: subjective cognitive decline, psychoaffective factors, cognitive performances, and atrophy progression over time. Alzheimers Res Ther. 2019 Jul 8;11(1):61. doi: 10.1186/s13195-019-0514-z.

  PMID: 31286994 DERIVED

• Gonneaud J, Arenaza-Urquijo EM, Fouquet M, Perrotin A, Fradin S, de La Sayette V, Eustache F, Chetelat G. Relative effect of APOE epsilon4 on neuroimaging biomarker changes across the lifespan. Neurology. 2016 Oct 18;87(16):1696-1703. doi: 10.1212/WNL.0000000000003234. Epub 2016 Sep 28.

  PMID: 27683850 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Apolipoprotein E4

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Apolipoproteins E; Apolipoproteins; Lipoproteins; Lipids; Apoproteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Vincent de La Sayette, MD

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2012
• First Posted: July 12, 2012
• Study Start: May 1, 2012
• Primary Completion: January 20, 2020
• Study Completion: September 20, 2022
• Last Updated: April 2, 2026

Record last verified: 2014-04

Locations

FR (7)