Cerebral Substrates of Prospective Memory in Young and Its Disruption in Normal Aging and in Alzheimer's Disease: A Study in Anatomical MRI, Diffusion Tensor MRI and Functional MRI

Alzheimer's Disease Clinical Trial

— IMPRO  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02522091
• Other study ID #: 10-002
• Status: Recruiting
• Phase: N/A
• First received: August 5, 2015
• Last updated: August 11, 2015
• Start date: November 2010

Study information

• Verified date: August 2015
• 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

Investigators propose in this study to evaluate prospective memory (MP) in all its complexity as well as the processes, cognitive and brain, the underlying. Specifically, investigators propose to evaluate the evolution of the MP during normal aging and Alzheimer's disease (AD) to identify the cognitive and brain processes underlying this development. To do this, this study will have to include healthy subjects, 18 to 95 years, patients with Mild Cognitive Impairment (MCI) and patients with probable AD. All participants will undergo a series of examinations, both neuropsychological and brain imaging.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All participants:

• Normal Education> 7 years

• French mother tongue

• right-handed (Edinburgh Inventory)

• score on the scale of Beck <7 (depression scale)

• signing the informed consent of the protocol in agreement with the Committee to Protect People

• Medical examinations, neurological, neuropsychological and neuroimaging depth in accordance with the specific inclusion and exclusion criteria for each population, that is to say:

• Young healthy subjects aged between 18 and 44 years

• Healthy subjects intermediate age: between 45 and 69 years

• score on the Mattis Dementia Scale higher than 137, in order to exclude any potential dementia

• Performance "normal" to test RI RL-16 (that is to say, not differing by more than 1.65 standard deviation from the norm for age and cultural level [see normative values published Van der Linden et al., 2004]), test conventionally used to assess the verbal episodic memory.

• Healthy elderly subjects aged 70 and over, living at home

• score on the Mattis Dementia Scale higher than 137, in order to exclude any potential dementia

• Performance "normal" to test RI RL-16 (that is to say, not differing by more than 1.65 standard deviation from the norm for age and cultural level [see normative values published Van der Linden et al., 2004]), test conventionally used to assess the verbal episodic memory.

• MCI patients: older than 50 years and recruited from memory clinics and meet the current criteria and recognized including amnestic MCI

• memory complaint

• targets deficits of episodic memory (lower performance of at least 1 standard deviation from the norm for age and cultural level to one or more (sub) episodic memory scores of diagnostic battery - cf. . Tables 1 and infra)

• performance in the standards for age and cultural level in all tests of diagnostic battery measuring other cognitive functions as memory, including the evaluation of overall cognitive ability tests.

• Alzheimer's patients: older than 50 years were recruited from the clinics and memory satisfying the standards NINCDS-ADRDA criteria for probable AD which include

• abnormal global cognitive functioning and deficits in two or more cognitive domains identified by the diagnostic battery

• mild to moderate AD (MMSE = 18).

Exclusion Criteria:

• Cognitive disorders of sudden onset (contrary to their slow and progressive onset in AD), which could reflect a stroke; a modified Hachinski ischemic score = 2 (Loeb & Gandolfo, 1983); history of head trauma with loss of consciousness for more than 1 hour, or encephalitis;

• Chronic neurological disease, psychiatric, endocrine, hepatic, infectious;

• A history of major illness (chronic lung disease, heart disorder, metabolic, hematologic, endocrine or immunological severe, cancer);

• A medication that may interfere with the mnemonic or metabolic measures (psychotropics, hypnotics, anxiolytics, neuroleptics, anti-Parkinson, benzodiazepines, anti-inflammatory drugs, antiepileptics, antihistamines, analgesics and muscle relaxants central, as is usual The investigating doctor deems the annoying character for the study of the regular intake of certain medications). Taking anticholinesterase treatment will also be a criterion for non-inclusion.

• Chronic intake of alcohol or drugs;

Study Design

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Device:
• functional brain MRI

Other:
• Neuropsychology tests

Locations

Country	Name	City	State
France	Service de neurologie	Caen, CHU

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measuring the amplitude of the BOLD signal (Blood Oxygen Level Dependent)		baseline	No