Multi-modal Neuroimaging in Alzheimer's Disease

Alzheimer's Disease Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01554202
• Other study ID #: 2007-A00414-49
• Status: Active, not recruiting
• Phase: N/A
• First received: March 13, 2012
• Last updated: March 5, 2013
• Start date: January 2008

Study information

• Verified date: March 2013
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 295
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Behavioral:
• assessment of memory

Biological:
• circulating tPA dosage

Genetic:
• ApoE4

Other:
• Brain imaging examination MRI and PET examinations

Locations

Country	Name	City	State
France	University Hospital Côte de Nacre	Caen
France	University Hospital Roger Salengro	Lille
France	University Hospital Pontchaillou	Rennes
France	University Hospital Rouen	Rouen
France	University Hospital Tours	Tours

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Caen	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (4)

Chételat 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. — View Citation

La Joie R, Fouquet M, Mézenge F, Landeau B, Villain N, Mevel K, Pélerin A, Eustache F, Desgranges B, Chételat 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. — View Citation

Mevel K, Grassiot B, Chételat 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. Review. French. — View Citation

Villain N, Landeau B, Groussard M, Mevel K, Fouquet M, Dayan J, Eustache F, Desgranges B, Chételat 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of volume change of whole brain, hippocampus and other structural MRI measures		3 years	No
Primary	Rate of Decline as measured by: Cognitive Tests, Activities of Daily Living, and CDR Sum of Boxes		3 years	No
Primary	Rates of change on each specified biochemical biomarker		3 years	No
Primary	Rates of change of glucose metabolism (FDG-PET)		3 years	No
Primary	Extent of amyloid deposition as measured by 18F-AV45		3 years	No
Primary	Group differences for each imaging and biomarker measurement		3 years	No
Primary	APOE genotype		3 years	No

External Links

•   Lab web site Inserm U1077