Clinical trial NCT02832921: Cognitive-motor Intervention Using Virtual Reality for Middle-aged Individuals at High Dementia Risk
Official title: Cognitive-motor Intervention Using Virtual Reality for Middle-aged Individuals at High Dementia Risk
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer's Disease (AD)
Keywords: Alzheimer's disease
virtual reality
cognitive training
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-07-14
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: change in overall cognition- measured by averaging z-scores from 14 paper and pencil neuropsychological tests covering episodic memory and executive functions cognitive domains.
timeFrame: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
measure: change in cerebral blood flow from arterial spin labeling (ASL)
timeFrame: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
Secondary outcomes:
measure: specific cognitive domains- average of z-scores of paper and pencil memory tests and of executive functions tests
timeFrame: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
measure: blood oxygenation level dependent (BOLD) functional MRI (fMRI) signal in the fronto-parietal network associated with working memory
timeFrame: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
measure: brain resting state functional connectivity by resting state network fMRI BOLD signal correlations
timeFrame: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
measure: hippocampal volume
timeFrame: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
measure: frontal inferior cortex volume
timeFrame: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
measure: white matter hyperintensity (WMH) burden
timeFrame: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
measure: diffusion-tensor imaging (DTI) measures
timeFrame: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center/Icahn School of Medicine at Mount Sinai
name: Michal Schnaider Beeri, PhD
role: PRINCIPAL_INVESTIGATOR
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