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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 (IMPRO)

Primary Purpose

Alzheimer's Disease

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
functional brain MRI
Neuropsychology tests
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alzheimer's Disease

Eligibility Criteria

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

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;

Sites / Locations

  • Service de neurologieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Other

Other

Other

Other

Other

Arm Label

young healthy volunteers (18-44 years old)

healthy volunteers (45-69 years old)

Mild Cognitive Impairment Patients

Alzheimer's Disease patient

old healthy volunteers (70+ years old)

Arm Description

young healthy volunteers (18-44 years old)

healthy volunteers (45-69 years old)

Mild Cognitive Impairment Patients

Alzheimer's Disease patient

old healthy volunteers (70+ years old)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 5, 2015
Last Updated
August 11, 2015
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT02522091
Brief Title
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
Acronym
IMPRO
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
178 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
young healthy volunteers (18-44 years old)
Arm Type
Other
Arm Description
young healthy volunteers (18-44 years old)
Arm Title
healthy volunteers (45-69 years old)
Arm Type
Other
Arm Description
healthy volunteers (45-69 years old)
Arm Title
Mild Cognitive Impairment Patients
Arm Type
Other
Arm Description
Mild Cognitive Impairment Patients
Arm Title
Alzheimer's Disease patient
Arm Type
Other
Arm Description
Alzheimer's Disease patient
Arm Title
old healthy volunteers (70+ years old)
Arm Type
Other
Arm Description
old healthy volunteers (70+ years old)
Intervention Type
Device
Intervention Name(s)
functional brain MRI
Intervention Type
Other
Intervention Name(s)
Neuropsychology tests
Primary Outcome Measure Information:
Title
measuring the amplitude of the BOLD signal (Blood Oxygen Level Dependent)
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Facility Information:
Facility Name
Service de neurologie
City
Caen, CHU
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent de la Sayette, MD, PhD
Phone
02.31.06.46.24

12. IPD Sharing Statement

Learn more about this trial

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

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