Alzheimer's DiseaseMALNCT02708485

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

A study testing Physical exercise in people with Alzheimer's Disease, run by Université de Sherbrooke at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: Alzheimer's Disease
What is being tested?: Physical exercise
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteCanada
Study dates: Apr 2009to Jul 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of mild Alzheimer's disease (NINCDS-ADRDA criteria)
Taking cholinesterase inhibitors
Sedentary
Ability to do physical exercise

Who cannot join

Parkinson disease
Down syndrome
Epilepsy or concussion
Drug or alcohol abuse
Past psychiatric history
Vitamin B12 Deficiency
Uncontrolled diabetes or thyroid function

Trial locations and contacts

1 site in 1 country.

Canada1 site

Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)
Sherbrooke, Quebec, J1H4C4

Other trials in Canada

About this study

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

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.

Conditions: Alzheimer's Disease
Being tested: Physical exercise
Medical subject headings: Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Physical exerciseOther
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).

Study groups in NCT02708485
Study group	Role	What they receive
Control group	No intervention	No intervention
Physical exercise	Experimental	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). Receives: Other: Physical exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

Brain Glucose Consumption
Brain glucose uptake (umol/100g/min) using 18F-FDG PET imaging
Measured: 3 months
Brain Acetoacetate Consumption
Brain acetoacetate uptake (umol/100g/min) using 11C-AcAc PET imaging
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Jul 2017

First posted15 Mar 2016 (estimated)
Study startApr 2009
Primary completionJul 2017
Study completionJul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
More trials run by Université de SherbrookeThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02708485
Sponsor's protocol ID: 09-043
Acronym: MAL
Status last verified: Jul 2017
First submitted: 10 Mar 2016
Last updated: 16 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Alzheimer's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02708485
Acronym / sponsor ID: MAL / 09-043
Conditions: Alzheimer's Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Université de SherbrookeUniversity, hospital or other
Study start: Apr 2009
Primary completion: Jul 2017 (actual)
Study completion: Jul 2017 (actual)
First posted: 15 Mar 2016 (estimated)
Results: Posted 16 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control group	No intervention	–No intervention
Physical exercise	Experimental	Other: Physical exerciseA 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).

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Diagnosis of mild Alzheimer's disease (NINCDS-ADRDA criteria)
Taking cholinesterase inhibitors
Sedentary
Ability to do physical exercise

Key exclusion criteria (7 listed)

Parkinson disease
Down syndrome
Epilepsy or concussion
Drug or alcohol abuse
Past psychiatric history

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Physical exerciseA 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

Primary outcome

Brain Glucose Consumption
Time frame: 3 months
Brain glucose uptake (umol/100g/min) using 18F-FDG PET imaging
Brain Acetoacetate Consumption
Time frame: 3 months
Brain acetoacetate uptake (umol/100g/min) using 11C-AcAc PET imaging

Results and safety

Results posted to the registry on 16 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Group	3	0
Physical Exercise	12	10

Primary outcome: Brain Glucose Consumption

Time frame: 3 months. Mean (Standard Deviation). Unit: umol/100 g/min

Measure	Control n = 0	Physical Exercise n = 10
Baseline	–	27.9 (3.2)
3-month	–	28.1 (3.4)

Population analysed: Participants of the Control group discontinued the study because of the intense imaging protocol without the possibility of some level of benefit (N=3)

Primary outcome: Brain Acetoacetate Consumption

Time frame: 3 months. Mean (Standard Deviation). Unit: umol/100 g/min

Measure	Control n = 0	Physical Exercise n = 10
Baseline	–	0.24 (0.12)
3-month	–	0.64 (0.40)

Population analysed: 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).

Adverse events

Time frame: All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Group	0 of 0	0 of 0	0
Physical Exercise	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Alzheimer's Disease

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Not yet recruiting
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nancy Paquet, MD principal investigator

Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke

Stephen Cunnane, PhD principal investigator

CDRV - CSSS-IUGS - CIUSSS de l'Estrie - CHUS

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Physical exercise in people with Alzheimer's Disease, run by Université de Sherbrooke at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brain Glucose Consumption (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02708485.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.