Effect of Walking on Brain Fuel Consumption in Mild Alzheimer's Disease (MAL)
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Physical exercise
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of mild Alzheimer's disease (NINCDS-ADRDA criteria)
- Taking cholinesterase inhibitors
- Sedentary
- Ability to do physical exercise
Exclusion Criteria:
- Parkinson disease
- Down syndrome
- Epilepsy or concussion
- Drug or alcohol abuse
- Past psychiatric history
- Vitamin B12 Deficiency
- Uncontrolled diabetes or thyroid function
Sites / Locations
- Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Physical exercise
Arm Description
No intervention
A 3-month walking program (3 times a week for 12 weeks) on treadmill supervised by a physiotherapist. Duration of the exercise is progressively increased from 15 min to 45 min over a 6-week period and the intensity of the exercise is moderate (a 12-13 score on Borg scale).
Outcomes
Primary Outcome Measures
Brain Glucose Consumption
Brain glucose uptake (umol/100g/min) using 18F-FDG PET imaging
Brain Acetoacetate Consumption
Brain acetoacetate uptake (umol/100g/min) using 11C-AcAc PET imaging
Secondary Outcome Measures
Full Information
NCT ID
NCT02708485
First Posted
March 10, 2016
Last Updated
December 14, 2017
Sponsor
Université de Sherbrooke
1. Study Identification
Unique Protocol Identification Number
NCT02708485
Brief Title
Effect of Walking on Brain Fuel Consumption in Mild Alzheimer's Disease
Acronym
MAL
Official Title
Evaluating the Impact of Physical Exercise on Mild Alzheimer's Disease in a Randomized Clinical Trial: Quantification With 18F -FDG and 11C- AcAc PET Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université de Sherbrooke
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to evaluate the effect of a 3-month walking program on brain energy metabolism in patient with mild Alzheimer's disease (AD). Two groups of sedentary patients with mild AD are followed and compared over a 3-month period of time: Control (non-active) and walking (from 15 to 45 minutes of exercise on a treadmill, 3 times a week for 12 weeks) groups. All the participants are evaluated on their cognition, brain volumes (MRI) and brain fuel consumption (PET scan with 18-FDG and 11C-AcAc) at the beginning and at the end of the study.
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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
Physical exercise
Arm Type
Experimental
Arm Description
A 3-month walking program (3 times a week for 12 weeks) on treadmill supervised by a physiotherapist. Duration of the exercise is progressively increased from 15 min to 45 min over a 6-week period and the intensity of the exercise is moderate (a 12-13 score on Borg scale).
Intervention Type
Other
Intervention Name(s)
Physical exercise
Intervention Description
A 3-month walking program (3 times a week for 12 weeks) on treadmill supervised by a physiotherapist. Duration of the exercise is progressively increased from 15 min to 45 min over a 6-week period and the intensity of the exercise is moderate (a 12-13 score on Borg scale).
Primary Outcome Measure Information:
Title
Brain Glucose Consumption
Description
Brain glucose uptake (umol/100g/min) using 18F-FDG PET imaging
Time Frame
3 months
Title
Brain Acetoacetate Consumption
Description
Brain acetoacetate uptake (umol/100g/min) using 11C-AcAc PET imaging
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of mild Alzheimer's disease (NINCDS-ADRDA criteria)
Taking cholinesterase inhibitors
Sedentary
Ability to do physical exercise
Exclusion Criteria:
Parkinson disease
Down syndrome
Epilepsy or concussion
Drug or alcohol abuse
Past psychiatric history
Vitamin B12 Deficiency
Uncontrolled diabetes or thyroid function
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Paquet, MD
Organizational Affiliation
Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen Cunnane, PhD
Organizational Affiliation
CDRV - CSSS-IUGS - CIUSSS de l'Estrie - CHUS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H4C4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Walking on Brain Fuel Consumption in Mild Alzheimer's Disease
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