Alzheimer's Disease
Conditions
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.
Interventions
OTHERPhysical 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).
Sponsors
Université de Sherbrooke
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain Glucose Consumption | 3 months | Brain glucose uptake (umol/100g/min) using 18F-FDG PET imaging |
| Brain Acetoacetate Consumption | 3 months | Brain acetoacetate uptake (umol/100g/min) using 11C-AcAc PET imaging |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control The Sedentary group received no active treatment. | 3 |
| 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). | 10 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Control | Physical Exercise | Total |
|---|---|---|---|
| Age, Continuous | 77 years STANDARD_DEVIATION 2 | 73 years STANDARD_DEVIATION 4 | 75 years STANDARD_DEVIATION 2 |
| Mini-Mental State Examination | 26 points | 26 points | 26 points |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Male | 0 Participants | 4 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Brain Acetoacetate Consumption
Brain acetoacetate uptake (umol/100g/min) using 11C-AcAc PET imaging
Time frame: 3 months
Population: Participants of the Control group discontinued the study because of the intense imaging protocol without the possibility of some level of benefit (N=3). Two participants in the Walking group decided to withdraw from the study prior to the commencement of the exercise program. There were no dropouts over the training period (N=10).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Physical Exercise | Brain Acetoacetate Consumption | Baseline | 0.24 umol/100 g/min | Standard Deviation 0.12 |
| Physical Exercise | Brain Acetoacetate Consumption | 3-month | 0.64 umol/100 g/min | Standard Deviation 0.4 |
Primary
Brain Glucose Consumption
Brain glucose uptake (umol/100g/min) using 18F-FDG PET imaging
Time frame: 3 months
Population: Participants of the Control group discontinued the study because of the intense imaging protocol without the possibility of some level of benefit (N=3)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Physical Exercise | Brain Glucose Consumption | Baseline | 27.9 umol/100 g/min | Standard Deviation 3.2 |
| Physical Exercise | Brain Glucose Consumption | 3-month | 28.1 umol/100 g/min | Standard Deviation 3.4 |