Effect of Walking on Brain Fuel Consumption in Mild Alzheimer's Disease
MAL
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
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 10, 2016
CompletedFirst Posted
Study publicly available on registry
March 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedResults Posted
Study results publicly available
October 16, 2018
CompletedOctober 16, 2018
July 1, 2017
8.3 years
March 10, 2016
July 27, 2017
December 14, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Brain Glucose Consumption
Brain glucose uptake (umol/100g/min) using 18F-FDG PET imaging
3 months
Brain Acetoacetate Consumption
Brain acetoacetate uptake (umol/100g/min) using 11C-AcAc PET imaging
3 months
Study Arms (2)
Control group
NO INTERVENTIONNo intervention
Physical exercise
EXPERIMENTALA 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).
Interventions
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).
Eligibility Criteria
You may qualify if:
- Diagnosis of mild Alzheimer's disease (NINCDS-ADRDA criteria)
- Taking cholinesterase inhibitors
- Sedentary
- Ability to do physical exercise
You may not qualify if:
- Parkinson disease
- Down syndrome
- Epilepsy or concussion
- Drug or alcohol abuse
- Past psychiatric history
- Vitamin B12 Deficiency
- Uncontrolled diabetes or thyroid function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)
Sherbrooke, Quebec, J1H4C4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stephen Cunnane
- Organization
- USherbrooke
Study Officials
- PRINCIPAL INVESTIGATOR
Nancy Paquet, MD
Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke
- PRINCIPAL INVESTIGATOR
Stephen Cunnane, PhD
CDRV - CSSS-IUGS - CIUSSS de l'Estrie - CHUS
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2016
First Posted
March 15, 2016
Study Start
April 1, 2009
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
October 16, 2018
Results First Posted
October 16, 2018
Record last verified: 2017-07