NCT06038643

Brief Summary

This is a four-week pilot randomized controlled trial of a behavioral intervention in older adults at risk for Alzheimer's disease. Older participants are a subgroup from the PREVENT-AD longitudinal cohort. We will test whether a four-week intergenerational social motivation using a technology-based platform (intervention group) enhances physical activity relative to a control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2022

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

October 8, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 9, 2025

Completed
Last Updated

July 9, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

April 25, 2022

Results QC Date

May 5, 2025

Last Update Submit

July 7, 2025

Conditions

Keywords

Risk FactorsDisease PreventionAlzheimer's DiseaseMotivation

Outcome Measures

Primary Outcomes (1)

  • Total Step Count (Average Steps/Day)

    This metric quantifies the change in the average number of steps taken each day, from the baseline period to the 4-week period. It is a marker of change in habitual ambulatory activity.

    4-week

Secondary Outcomes (14)

  • The Modified Differential Emotions Scale (mDES) Negative Emotions

    4 weeks

  • Generativity - Achievement

    4 weeks

  • Test My Brain Digital Neuropsychology Toolkit - Backwards Digit Span

    4 weeks

  • Loneliness

    4 weeks

  • Modified Differential Emotions Scale (mDES) Positive Emotions

    4 weeks

  • +9 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Social motivation intervention, self-transcendence daily messages, and daily accelerometry.

Behavioral: Motivational behavioural intervention and daily activities monitoring

Active Control

ACTIVE COMPARATOR

Daily accelerometry.

Behavioral: Active Control

Interventions

Social motivation manipulation, self-transcendence daily messaging, and daily activities monitoring through accelerometry. Participants in this arm will have a study partner who receives daily feedback on the main participant's daily step count.

Intervention
Active ControlBEHAVIORAL

Daily activities monitored through accelerometry.

Active Control

Eligibility Criteria

Age60 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women \> 60 years Who are current participants of the PREVENT-AD Longitudinal Cohort at McGill University.
  • No contraindications to MRI Imaging. Normal cognition Not exercising more than 150 minutes of moderate-intensity exercise per week or sitting more than 8 hours per day AND responded "yes" to the question "Do you want to increase your physical activity?" Fluency in English or French Access to a computer or smartphone with internet Normal or corrected-to-normal vision based on the minimal 20/20 standard Ambulatory without significant increase in pain with walking or the assistance of walking devices

You may not qualify if:

  • Primary care physician does not approve additional physical activity An inability to ambulate without the assistance of another person or severe pain
  • Any unstable medical condition:
  • History of a psychiatric illness including schizophrenia or Attention Deficit Hyperactivity Disorder (ADHD). History of anxiety or depression accepted if stable on medication for at least 6 months
  • Current treatment for cancer - except non-melanoma skin cancer
  • Neurological condition (e.g., multiple sclerosis, Parkinson's disease, and stroke)
  • Current alcohol or substance abuse
  • Current treatment for congestive heart failure, angina, uncontrolled arrhythmia, Deep Venous Thrombosis (DVT) or other unstable cardiovascular condition
  • Myocardial infarction, coronary artery bypass grafting, angioplasty or other cardiac event in the past six months.
  • Can be identified as child or grandchild of participant (biological or adopted), 14 years or older.
  • Can be a young adult (18 years or older) who is not a relative of the main participant, in case a grandchild or child is not available.
  • Stable on antidepressants for more than 6 months.
  • In contact with the primary participant more than once per 12 months at baseline
  • Lives anywhere in Canada if 18 years and older, or anywhere accessible by mail in Quebec if 14 years and older but younger than 18 years.
  • Normal or corrected-to-normal vision based on the minimal 20/20 standard to complete the cognitive tasks
  • Able to speak, read, and write English or French
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Douglas Mental Health University Institute

Montreal, Quebec, H4H 1R3, Canada

Location

MeSH Terms

Conditions

Sedentary BehaviorAlzheimer Disease

Condition Hierarchy (Ancestors)

BehaviorDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Maiya R. Geddes
Organization
McGill University

Study Officials

  • Maiya R Geddes, MD PhD

    McGill University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Intergenerational Social Motivation Behavioral Intervention using a Technology-based Platform Our research will test an innovative, technology-based, and readily scalable cross-generational social behavior intervention to enhance physical activity in at-risk older adults through a randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 25, 2022

First Posted

September 15, 2023

Study Start

October 8, 2023

Primary Completion

April 14, 2024

Study Completion

May 30, 2024

Last Updated

July 9, 2025

Results First Posted

July 9, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations