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

Sheba Medical Center200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

200

Conditions

Alzheimer's Disease (AD)

Interventions

cognitive training by virtual realityBEHAVIORAL

watching a scientific TV documentaryBEHAVIORAL

treadmillDEVICE

VR cognitive training will be augmented by walking on a treadmill, since it is well established that dual tasking-i.e. performing the VR-based cognitive effort together with a motor task, even as simple as walking on a treadmill-places greater demand on cognitive resources than a "single task".

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

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.

summary of the z-scores of all 14 paper and pencil cognitive tests

Time frame: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)

change in cerebral blood flow from arterial spin labeling (ASL)

acquired by structural MRI using background-suppressed pseudo-continuous ASL (pcASL) featuring a 3D fast spin echo spiral sequence

Time frame: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)

Secondary Outcomes

specific cognitive domains- average of z-scores of paper and pencil memory tests and of executive functions tests

summary of z-scores of executive functions tests and of episodic memory tests

Time frame: 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

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

Time frame: 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

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

Central Contacts

Glen M Doniger, PhD

CONTACT

Glen.Doniger@sheba.health.gov.il

Data from ClinicalTrials.gov

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