Alzheimer's Disease (AD)
Conditions
Keywords
Alzheimer's disease, virtual reality, cognitive training
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.
Interventions
BEHAVIORALcognitive training by virtual reality
BEHAVIORALwatching a scientific TV documentary
DEVICEtreadmill
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.
Sponsors
Sheba Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Israel
Contacts
Primary ContactGlen M Doniger, PhD
Outcome results
None listed