Alzheimer's Disease (AD)NCT02832921
Cognitive-motor Intervention Using Virtual Reality for Middle-aged Individuals at High Dementia Risk
A study testing cognitive training by virtual reality, watching a scientific TV documentary and treadmill in people with Alzheimer's Disease (AD), run by Sheba Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease (AD)
- What is being tested?
- cognitive training by virtual reality, watching a scientific TV documentary and treadmill
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2016to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Glen M Doniger, PhD contact
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
Glen M Doniger, PhD, Glen.Doniger@sheba.health.gov.il
About this study
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.
- Conditions
- Alzheimer's Disease (AD)
- Being tested
- cognitive training by virtual reality, watching a scientific TV documentary, treadmill
- Keywords
- Alzheimer's disease, virtual reality, cognitive training
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive training by virtual realityBehavioural
watching a scientific TV documentaryBehavioural
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".
| Study group | Role | What they receive |
|---|---|---|
| VR cognitive tasks + treadmill | Experimental | This is the primary group of interest, in which the investigators hypothesize the greatest cognitive gains since motor activity will augment cognitive activity. Receives: Behavioral: cognitive training by virtual reality; Device: treadmill |
| VR cognitive tasks - treadmill | Active comparator | 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. Receives: Behavioral: cognitive training by virtual reality |
| scientific TV documentary + treadmill | Sham comparator | 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. Receives: Behavioral: watching a scientific TV documentary; Device: treadmill |
| Passive control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
hippocampal volume
3D T1-weighted MRI imaging
Measured: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
frontal inferior cortex volume
3D T1-weighted MRI imaging
Measured: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
white matter hyperintensity (WMH) burden
3D T2-FLAIR MRI imaging
Measured: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
diffusion-tensor imaging (DTI) measures
diffusion-weighted MRI imaging (DWI) to map white matter tractography
Measured: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's Disease (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Michal Schnaider Beeri, PhD, Principal investigator, Sheba Medical Center/Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832921
- Sponsor's protocol ID
- SHEBA-16-2988-MSB-CTIL
- Status last verified
- Jan 2018
- First submitted
- 26 Jun 2016
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26311488Lazarov 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.
PubMed 15766532Gould 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.
PubMed 10220454Gould 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.
PubMed 10521353Stern 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.
PubMed 23079557Esiri 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.
PubMed 22380508Gaitan 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.
PubMed 22473855Gates 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.
PubMed 21510896Rebok 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.
PubMed 24417410Hausdorff 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.
PubMed 19126846Optale 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.
PubMed 19934445Man 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.
PubMed 21681818Tarraga 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.
PubMed 16820420Birdsill 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.
PubMed 23687103Gommer 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.
PubMed 22460326
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-motor Intervention Using Virtual Reality for Middle-aged Individuals at High Dementia Risk
- ClinicalTrials.gov ID
- NCT02832921
- Acronym / sponsor ID
- SHEBA-16-2988-MSB-CTIL
- Conditions
- Alzheimer's Disease (AD)
- Keywords
- Alzheimer's disease, virtual reality, cognitive training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jul 2016
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VR cognitive tasks + treadmill | Experimental | Behavioral: cognitive training by virtual reality, Device: treadmillThis is the primary group of interest, in which the investigators hypothesize the greatest cognitive gains since motor activity will augment cognitive activity. |
| VR cognitive tasks - treadmill | Active comparator | Behavioral: cognitive training by virtual realityThis 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. |
| scientific TV documentary + treadmill | Sham comparator | Behavioral: watching a scientific TV documentary, Device: treadmillThis 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. |
| Passive control | No intervention | –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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive training by virtual reality | Behavioural | VR cognitive tasks + treadmill, VR cognitive tasks - treadmill |
| watching a scientific TV documentary | Behavioural | scientific TV documentary + treadmill |
| treadmillVR 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". | Device | VR cognitive tasks + treadmill, scientific TV documentary + treadmill |
Primary outcome
change in overall cognition- measured by averaging z-scores from 14 paper and pencil neuropsychological tests covering episodic memory and executive functions cognitive domains.
Time frame: 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)
Time frame: 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
7 secondary outcomes
specific cognitive domains- average of z-scores of paper and pencil memory tests and of executive functions 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
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
Time frame: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
hippocampal volume
Time frame: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
frontal inferior cortex volume
Time frame: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
white matter hyperintensity (WMH) burden
Time frame: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
diffusion-tensor imaging (DTI) measures
Time frame: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Background: PubMed 26311488Garthe 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.
- Background: PubMed 15766532Lazarov 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.
- Background: PubMed 10220454Gould 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.
- Background: PubMed 10521353Gould 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.
- Background: PubMed 23079557Stern 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.
- Background: PubMed 22380508Esiri 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.
- Background: PubMed 22473855Gaitan 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.
- Background: PubMed 21510896Gates 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.
- Background: PubMed 24417410Rebok 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.
- Background: PubMed 19126846Hausdorff 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.
- Background: PubMed 19934445Optale 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.
- Background: PubMed 21681818Man 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glen M Doniger, PhD contact
Michal Schnaider Beeri, PhD principal investigator
Sheba Medical Center/Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive training by virtual reality, watching a scientific TV documentary and treadmill in people with Alzheimer's Disease (AD), run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Glen M Doniger, PhD (Glen.Doniger@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02832921, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2018.