Cognitive-motor Intervention Using Virtual Reality for Middle-aged Individuals at High Dementia Risk
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alzheimer's Disease (AD)
- Sponsor
- Sheba Medical Center
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- change in overall cognition- measured by averaging z-scores from 14 paper and pencil neuropsychological tests covering episodic memory and executive functions cognitive domains.
- Last Updated
- 8 years ago
Overview
Brief Summary
The primary objective of this program is to apply a virtual reality (VR) cognitive-motor intervention (compared to active and passive control groups) to delay or slow cognitive decline of middle-aged adults who have a family history of Alzheimer's disease (AD) and thus are at particularly high risk of developing the disease.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The participants of the study must have at least one parent with Alzheimer's disease.
- •Fluency in Hebrew, in order to understand the instructions of the cognitive tests.
- •Availability of an informant for the participant.
Exclusion Criteria
- •Severe neurological or psychological conditions that may affect cognitive performance.
- •Substantial orthopedic limitations which prevent the use of treadmill.
- •Unstable medical condition such as an active cancer.
- •Incapability of adherence to the training program.
- •The participant is undergoing a treatment that may interfere with the study program.
Outcomes
Primary Outcomes
change in overall cognition- measured by averaging z-scores from 14 paper and pencil neuropsychological tests covering episodic memory and executive functions cognitive domains.
Time Frame: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
summary of the z-scores of all 14 paper and pencil cognitive tests
change in cerebral blood flow from arterial spin labeling (ASL)
Time Frame: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
acquired by structural MRI using background-suppressed pseudo-continuous ASL (pcASL) featuring a 3D fast spin echo spiral sequence
Secondary Outcomes
- hippocampal volume(baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group))
- frontal inferior cortex volume(baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group))
- white matter hyperintensity (WMH) burden(baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group))
- specific cognitive domains- average of z-scores of paper and pencil memory tests and of executive functions tests(baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group))
- blood oxygenation level dependent (BOLD) functional MRI (fMRI) signal in the fronto-parietal network associated with working memory(baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group))
- brain resting state functional connectivity by resting state network fMRI BOLD signal correlations(baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group))
- diffusion-tensor imaging (DTI) measures(baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group))