Cognitive-motor Intervention Using Virtual Reality for Middle-aged Individuals at High Dementia Risk

Not Applicable

• Conditions: Alzheimer's Disease (AD)

• Registration Number: NCT02832921
• Lead Sponsor: Sheba Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-26
• Study Start: 2016-07
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-14
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-24
• Last Update Posted: 2018-01-26
• Primary Completion: 2019-07
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change in overall cognition- measured by averaging z-scores from 14 paper and pencil neuropsychological tests covering episodic memory and executive functions cognitive domains.	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)	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 Outcome Measures

Name	Time	Method
hippocampal volume	baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)	3D T1-weighted MRI imaging
frontal inferior cortex volume	baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)	3D T1-weighted MRI imaging
white matter hyperintensity (WMH) burden	baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)	3D T2-FLAIR MRI imaging
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)	summary of z-scores of executive functions tests and of episodic memory tests
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)	T2\*-weighted fMRI during an n-back working memory task; contrasts: 1-back minus 0-back; 2-back minus 0-back; 2-back minus 1-back
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)	T2\*-weighted fMRI while relaxing with eyes closed; functional connectivity between seed regions of resting state networks (e.g., default mode, attentional, salience) and other regions by correlation of BOLD signal in seed regions with that in other regions
diffusion-tensor imaging (DTI) measures	baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)	diffusion-weighted MRI imaging (DWI) to map white matter tractography

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel