NCT02708485

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 16, 2018

Completed
Last Updated

October 16, 2018

Status Verified

July 1, 2017

Enrollment Period

8.3 years

First QC Date

March 10, 2016

Results QC Date

July 27, 2017

Last Update Submit

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 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).

Other: Physical exercise

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).

Physical exercise

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Stephen Cunnane
Organization
USherbrooke

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

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

Locations