Back to resultsCognitive-motor Intervention Using Virtual Reality for Middle-aged Individuals at High Dementia Risk
Primary Purpose
Alzheimer's Disease (AD)
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
cognitive training by virtual reality
watching a scientific TV documentary
treadmill
Sponsored by
About this trial
This is an interventional prevention trial for Alzheimer's Disease (AD) focused on measuring Alzheimer's disease, virtual reality, cognitive training
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.
Sites / Locations
- Sheba Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Sham Comparator
No Intervention
Arm Label
VR cognitive tasks + treadmill
VR cognitive tasks - treadmill
scientific TV documentary + treadmill
Passive control
Arm Description
This is the primary group of interest, in which the investigators hypothesize the greatest cognitive gains since motor activity will augment cognitive activity.
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.
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.
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.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
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
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
hippocampal volume
3D T1-weighted MRI imaging
frontal inferior cortex volume
3D T1-weighted MRI imaging
white matter hyperintensity (WMH) burden
3D T2-FLAIR MRI imaging
diffusion-tensor imaging (DTI) measures
diffusion-weighted MRI imaging (DWI) to map white matter tractography
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02832921
Brief Title
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
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease (AD)
Keywords
Alzheimer's disease, virtual reality, cognitive training
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VR cognitive tasks + treadmill
Arm Type
Experimental
Arm Description
This is the primary group of interest, in which the investigators hypothesize the greatest cognitive gains since motor activity will augment cognitive activity.
Arm Title
VR cognitive tasks - treadmill
Arm Type
Active Comparator
Arm 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.
Arm Title
scientific TV documentary + treadmill
Arm Type
Sham Comparator
Arm 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.
Arm Title
Passive control
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
cognitive training by virtual reality
Intervention Type
Behavioral
Intervention Name(s)
watching a scientific TV documentary
Intervention Type
Device
Intervention Name(s)
treadmill
Intervention Description
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".
Primary Outcome Measure Information:
Title
change in overall cognition- measured by averaging z-scores from 14 paper and pencil neuropsychological tests covering episodic memory and executive functions cognitive domains.
Description
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)
Title
change in cerebral blood flow from arterial spin labeling (ASL)
Description
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 Outcome Measure Information:
Title
specific cognitive domains- average of z-scores of paper and pencil memory tests and of executive functions tests
Description
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)
Title
blood oxygenation level dependent (BOLD) functional MRI (fMRI) signal in the fronto-parietal network associated with working memory
Description
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)
Title
brain resting state functional connectivity by resting state network fMRI BOLD signal correlations
Description
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
Time Frame
baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
Title
hippocampal volume
Description
3D T1-weighted MRI imaging
Time Frame
baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
Title
frontal inferior cortex volume
Description
3D T1-weighted MRI imaging
Time Frame
baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
Title
white matter hyperintensity (WMH) burden
Description
3D T2-FLAIR MRI imaging
Time Frame
baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
Title
diffusion-tensor imaging (DTI) measures
Description
diffusion-weighted MRI imaging (DWI) to map white matter tractography
Time Frame
baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Glen M Doniger, PhD
Email
Glen.Doniger@sheba.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michal Schnaider Beeri, PhD
Organizational Affiliation
Sheba Medical Center/Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Glen M Doniger, PhD
Email
Glen.Doniger@sheba.health.gov.il
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26311488
Citation
Garthe A, Roeder I, Kempermann G. Mice in an enriched environment learn more flexibly because of adult hippocampal neurogenesis. Hippocampus. 2016 Feb;26(2):261-71. doi: 10.1002/hipo.22520. Epub 2015 Sep 15.
Results Reference
background
PubMed Identifier
15766532
Citation
Lazarov O, Robinson J, Tang YP, Hairston IS, Korade-Mirnics Z, Lee VM, Hersh LB, Sapolsky RM, Mirnics K, Sisodia SS. Environmental enrichment reduces Abeta levels and amyloid deposition in transgenic mice. Cell. 2005 Mar 11;120(5):701-13. doi: 10.1016/j.cell.2005.01.015.
Results Reference
background
PubMed Identifier
10220454
Citation
Gould E, Reeves AJ, Fallah M, Tanapat P, Gross CG, Fuchs E. Hippocampal neurogenesis in adult Old World primates. Proc Natl Acad Sci U S A. 1999 Apr 27;96(9):5263-7. doi: 10.1073/pnas.96.9.5263.
Results Reference
background
PubMed Identifier
10521353
Citation
Gould E, Reeves AJ, Graziano MS, Gross CG. Neurogenesis in the neocortex of adult primates. Science. 1999 Oct 15;286(5439):548-52. doi: 10.1126/science.286.5439.548.
Results Reference
background
PubMed Identifier
23079557
Citation
Stern Y. Cognitive reserve in ageing and Alzheimer's disease. Lancet Neurol. 2012 Nov;11(11):1006-12. doi: 10.1016/S1474-4422(12)70191-6.
Results Reference
background
PubMed Identifier
22380508
Citation
Esiri MM, Chance SA. Cognitive reserve, cortical plasticity and resistance to Alzheimer's disease. Alzheimers Res Ther. 2012 Mar 1;4(2):7. doi: 10.1186/alzrt105.
Results Reference
background
PubMed Identifier
22473855
Citation
Gaitan A, Garolera M, Cerulla N, Chico G, Rodriguez-Querol M, Canela-Soler J. Efficacy of an adjunctive computer-based cognitive training program in amnestic mild cognitive impairment and Alzheimer's disease: a single-blind, randomized clinical trial. Int J Geriatr Psychiatry. 2013 Jan;28(1):91-9. doi: 10.1002/gps.3794. Epub 2012 Apr 3.
Results Reference
background
PubMed Identifier
21510896
Citation
Gates NJ, Valenzuela M, Sachdev PS, Singh NA, Baune BT, Brodaty H, Suo C, Jain N, Wilson GC, Wang Y, Baker MK, Williamson D, Foroughi N, Fiatarone Singh MA. Study of Mental Activity and Regular Training (SMART) in at risk individuals: a randomised double blind, sham controlled, longitudinal trial. BMC Geriatr. 2011 Apr 21;11:19. doi: 10.1186/1471-2318-11-19.
Results Reference
background
PubMed Identifier
24417410
Citation
Rebok GW, Ball K, Guey LT, Jones RN, Kim HY, King JW, Marsiske M, Morris JN, Tennstedt SL, Unverzagt FW, Willis SL; ACTIVE Study Group. Ten-year effects of the advanced cognitive training for independent and vital elderly cognitive training trial on cognition and everyday functioning in older adults. J Am Geriatr Soc. 2014 Jan;62(1):16-24. doi: 10.1111/jgs.12607. Epub 2014 Jan 13.
Results Reference
background
PubMed Identifier
19126846
Citation
Hausdorff JM, Schweiger A, Herman T, Yogev-Seligmann G, Giladi N. Dual-task decrements in gait: contributing factors among healthy older adults. J Gerontol A Biol Sci Med Sci. 2008 Dec;63(12):1335-43. doi: 10.1093/gerona/63.12.1335.
Results Reference
background
PubMed Identifier
19934445
Citation
Optale G, Urgesi C, Busato V, Marin S, Piron L, Priftis K, Gamberini L, Capodieci S, Bordin A. Controlling memory impairment in elderly adults using virtual reality memory training: a randomized controlled pilot study. Neurorehabil Neural Repair. 2010 May;24(4):348-57. doi: 10.1177/1545968309353328. Epub 2009 Nov 24.
Results Reference
background
PubMed Identifier
21681818
Citation
Man DW, Chung JC, Lee GY. Evaluation of a virtual reality-based memory training programme for Hong Kong Chinese older adults with questionable dementia: a pilot study. Int J Geriatr Psychiatry. 2012 May;27(5):513-20. doi: 10.1002/gps.2746. Epub 2011 Jun 17.
Results Reference
background
PubMed Identifier
16820420
Citation
Tarraga L, Boada M, Modinos G, Espinosa A, Diego S, Morera A, Guitart M, Balcells J, Lopez OL, Becker JT. A randomised pilot study to assess the efficacy of an interactive, multimedia tool of cognitive stimulation in Alzheimer's disease. J Neurol Neurosurg Psychiatry. 2006 Oct;77(10):1116-21. doi: 10.1136/jnnp.2005.086074. Epub 2006 Jul 4.
Results Reference
background
PubMed Identifier
23687103
Citation
Birdsill AC, Carlsson CM, Willette AA, Okonkwo OC, Johnson SC, Xu G, Oh JM, Gallagher CL, Koscik RL, Jonaitis EM, Hermann BP, LaRue A, Rowley HA, Asthana S, Sager MA, Bendlin BB. Low cerebral blood flow is associated with lower memory function in metabolic syndrome. Obesity (Silver Spring). 2013 Jul;21(7):1313-20. doi: 10.1002/oby.20170. Epub 2013 May 19.
Results Reference
background
PubMed Identifier
22460326
Citation
Gommer ED, Martens EG, Aalten P, Shijaku E, Verhey FR, Mess WH, Ramakers IH, Reulen JP. Dynamic cerebral autoregulation in subjects with Alzheimer's disease, mild cognitive impairment, and controls: evidence for increased peripheral vascular resistance with possible predictive value. J Alzheimers Dis. 2012;30(4):805-13. doi: 10.3233/JAD-2012-111628.
Results Reference
background
PubMed Identifier
25150735
Citation
Beeri MS, Ravona-Springer R, Moshier E, Schmeidler J, Godbold J, Karpati T, Leroith D, Koifman K, Kravitz E, Price R, Hoffman H, Silverman JM, Heymann A. The Israel Diabetes and Cognitive Decline (IDCD) study: Design and baseline characteristics. Alzheimers Dement. 2014 Nov;10(6):769-78. doi: 10.1016/j.jalz.2014.06.002. Epub 2014 Aug 20.
Results Reference
background
PubMed Identifier
23477989
Citation
Villemagne VL, Burnham S, Bourgeat P, Brown B, Ellis KA, Salvado O, Szoeke C, Macaulay SL, Martins R, Maruff P, Ames D, Rowe CC, Masters CL; Australian Imaging Biomarkers and Lifestyle (AIBL) Research Group. Amyloid beta deposition, neurodegeneration, and cognitive decline in sporadic Alzheimer's disease: a prospective cohort study. Lancet Neurol. 2013 Apr;12(4):357-67. doi: 10.1016/S1474-4422(13)70044-9. Epub 2013 Mar 8.
Results Reference
background
PubMed Identifier
26753062
Citation
Bauckneht M, Picco A, Nobili F, Morbelli S. Amyloid positron emission tomography and cognitive reserve. World J Radiol. 2015 Dec 28;7(12):475-83. doi: 10.4329/wjr.v7.i12.475.
Results Reference
background
PubMed Identifier
25024328
Citation
Van der Mussele S, Fransen E, Struyfs H, Luyckx J, Marien P, Saerens J, Somers N, Goeman J, De Deyn PP, Engelborghs S. Depression in mild cognitive impairment is associated with progression to Alzheimer's disease: a longitudinal study. J Alzheimers Dis. 2014;42(4):1239-50. doi: 10.3233/JAD-140405.
Results Reference
background
Learn more about this trial
Cognitive-motor Intervention Using Virtual Reality for Middle-aged Individuals at High Dementia Risk
We'll reach out to this number within 24 hrs