NCT02522091

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

5.1 years

First QC Date

August 5, 2015

Last Update Submit

August 11, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • measuring the amplitude of the BOLD signal (Blood Oxygen Level Dependent)

    baseline

Study Arms (5)

young healthy volunteers (18-44 years old)

OTHER

young healthy volunteers (18-44 years old)

Device: functional brain MRIOther: Neuropsychology tests

healthy volunteers (45-69 years old)

OTHER

healthy volunteers (45-69 years old)

Device: functional brain MRIOther: Neuropsychology tests

Mild Cognitive Impairment Patients

OTHER

Mild Cognitive Impairment Patients

Device: functional brain MRIOther: Neuropsychology tests

Alzheimer's Disease patient

OTHER

Alzheimer's Disease patient

Device: functional brain MRIOther: Neuropsychology tests

old healthy volunteers (70+ years old)

OTHER

old healthy volunteers (70+ years old)

Device: functional brain MRIOther: Neuropsychology tests

Interventions

Alzheimer's Disease patientMild Cognitive Impairment Patientshealthy volunteers (45-69 years old)old healthy volunteers (70+ years old)young healthy volunteers (18-44 years old)
Alzheimer's Disease patientMild Cognitive Impairment Patientshealthy volunteers (45-69 years old)old healthy volunteers (70+ years old)young healthy volunteers (18-44 years old)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).
  • 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;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de neurologie

Caen, CHU, 14000, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2015

First Posted

August 13, 2015

Study Start

November 1, 2010

Primary Completion

December 1, 2015

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations