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

Sheba Medical Center

Status: Unknown

Conditions: Alzheimer's Disease (AD)

Treatments: Behavioral: cognitive training by virtual reality; Behavioral: watching a scientific TV documentary; Device: treadmill

Study type: Interventional

Funder types: Other

Identifiers

NCT02832921

SHEBA-16-2988-MSB-CTIL

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 4 patient groups

VR cognitive tasks + treadmill

Experimental group

Description:

This is the primary group of interest, in which the investigators hypothesize the greatest cognitive gains since motor activity will augment cognitive activity.

Treatment:

Behavioral: cognitive training by virtual reality

Device: treadmill

VR cognitive tasks - treadmill

Active Comparator group

Description:

This group will be an active control, receiving the VR cognitive training without treadmill walking, to examine whether the motor component augments the effect of the VR in the experimental group.

Treatment:

Behavioral: cognitive training by virtual reality

scientific TV documentary + treadmill

Sham Comparator group

Description:

This group will watch a scientific TV documentary while walking on the treadmill. This control group will permit examination of whether the VR cognitive training, which requires an especially active cognitive effort while walking on the treadmill, is more advantageous than passively watching a scientific TV documentary while performing the same motor task as the experimental group.

Treatment:

Behavioral: watching a scientific TV documentary

Device: treadmill

Passive control

No Intervention group

Description:

This group of participants will not receive any intervention but will be assessed with the same battery of assessments as the other three groups, permitting comparisons of the cognitive and neurobiological outcomes of the intervention groups to that of the natural course of decline/deterioration of these at-risk individuals.