NCT01038726

Brief Summary

The purpose of this study is to gain a better understanding of the effects of exercise and cognitive training on improving brain function in healthy older adults who may be at risk for developing Alzheimer's Disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2009

Typical duration 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

December 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 24, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

September 18, 2013

Status Verified

September 1, 2013

Enrollment Period

2.8 years

First QC Date

December 21, 2009

Last Update Submit

September 17, 2013

Conditions

AgingAlzheimer's Disease

Keywords

Healthy Aging

Outcome Measures

Primary Outcomes (1)

  • Brain activation patterns measured by functional MRI

    baseline and 12 weeks

Secondary Outcomes (2)

  • Neuropsychological Testing

    baseline and 12 weeks

  • Exercise assessment

    baseline and 12 weeks

Study Arms (4)

Exercise Training

ACTIVE COMPARATOR
Other: Exercise Training

Combined Cognitive/Exercise Training

ACTIVE COMPARATOR
Other: Exercise TrainingOther: Cognitive Training

Cognitive Training

ACTIVE COMPARATOR
Other: Cognitive Training

Combined Low Intensity Training

ACTIVE COMPARATOR
Other: Flexibility TrainingOther: Educational Sessions

Interventions

Exercise TrainingOTHER

Aerobic exercise training program designed by the Cardiac Rehabilitation department

Combined Cognitive/Exercise TrainingExercise Training
Cognitive TrainingOTHER

Based on cognitive training program Brain Fitness®

Cognitive TrainingCombined Cognitive/Exercise Training
Flexibility TrainingOTHER

Non-aerobic flexibility training program designed by the Cardiac Rehabilitation department

Combined Low Intensity Training
Educational SessionsOTHER

DVD-based educational programs on history, art, and literature

Combined Low Intensity Training

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First or Second-degree relative of someone with Alzheimer's Disease
  • Not currently engaging in regular exercise
  • Able to undergo an MRI
  • Fluent in English

You may not qualify if:

  • Neurological illnesses/conditions
  • Medical illness/conditions that may affect brain function
  • Any unstable or severe cardiovascular disease or asthmatic condition
  • Severe depressive symptoms
  • Inability to walk unassisted

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

ExerciseCognitive Training

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNeurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Stephen M Rao, Ph.D.

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2009

First Posted

December 24, 2009

Study Start

December 1, 2009

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

September 18, 2013

Record last verified: 2013-09

Locations

US(1)