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Effect of Walking on Brain Fuel Consumption in Mild Alzheimer's Disease (MAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02708485
Recruitment Status : Completed
First Posted : March 15, 2016
Results First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Université de Sherbrooke

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Other: Physical exercise Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2009
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

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Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control group
No intervention
Experimental: Physical exercise
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).
 Other: Physical exercise
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).


Outcome Measures
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Primary Outcome Measures :
  1. Brain Glucose Consumption [ Time Frame: 3 months ]
    Brain glucose uptake (umol/100g/min) using 18F-FDG PET imaging

  2. Brain Acetoacetate Consumption [ Time Frame: 3 months ]
    Brain acetoacetate uptake (umol/100g/min) using 11C-AcAc PET imaging


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02708485


Locations
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Canada, Quebec
Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)
Sherbrooke, Quebec, Canada, J1H4C4
Sponsors and Collaborators
Université de Sherbrooke
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Université de Sherbrooke:
Study Protocol and Statistical Analysis Plan  [PDF] August 29, 2017

More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT02708485    
Other Study ID Numbers: 09-043
First Posted: March 15, 2016    Key Record Dates
Results First Posted: October 16, 2018
Last Update Posted: October 16, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders