Alzheimer DiseaseTADFNCT04732182
Telerehabilitation Alzheimer's Disease Feasibility (TADF)
A study testing BrightGo cognitive training in people with Alzheimer Disease and Healthy Aging, run by Bright Cloud International Corp at 2 sites in United States.
Trial summary
This is a pilot RCT with equal arms: experimental arm and (wait list) control arm. All participants will be in the early stage of Alzheimer's disease and on stable medication. They will all continue with this medication for their 6 months participation. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Healthy Aging
- What is being tested?
- BrightGo cognitive training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Feb 2022to 28 Feb 2023
- 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65 to 85;
- Diagnosis of early Alzheimer's (Montreal Cognitive Assessment [MoCA] score of 19-25) [Nasreddine et al 2005].
- English speakers;
- Ability to actively move UE and to flex/extend fingers;
- Stable on Aricept 10 mg daily intake or Exelon 9.5 mg patch medication
- Able to consent;
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- Living in the community in Central Jersey so to facilitate researchers travel to home for system installation and/or repairs,
- Living with a caregiver willing to support trials and be present during sessions;
- Good upper extremity motor function, close to full range of movement of arms and fingers.
Who cannot join
- Those younger than 65;
- Participating in other research studies;
- Severe visual impairments or legally blind;
- Severe hearing loss or deafness;
- Uncontrolled hypertension (>190/100 mmHg);
- Severe cognitive delay (MoCA <19);
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- non-English speakers;
- Those unable to provide consent;
- Unable to move arms and fingers, or with severe arthritis;
- Severe propensity to simulation sickness;
- Those who are not cooperative with the evaluations pre-study ;
- Those who cannot produce reliable scores on the neuropsychological pre-study assessment because they do not comprehend the test, or have severe speech impairment;
- Those not living with a caregiver willing to support trials, and caregiver unwilling or unable to be present during sessions;
- Those that are unwilling allow home inspections to ascertain internet conditions in the home, to determine best placement for the experimental system, to install and remove system, and to provide repairs if needed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Rutgers, The State University of New Jersey
New Brunswick, New Jersey, 08901-2066
Jasdeep S Hundal, PsyD, 732-235-6332, jsh164@rwjms.rutgers.edu
Daniel Valdivia, B.S., 2013164424, djv85@gsbs.rutgers.edu
- Recruiting
Bright Cloud Int'l Corp
North Brunswick, New Jersey, 08902
Grigore C Burdea, PhD, 908-406-9334, diplomatru@yahoo.com
Edward A Berde, MS, 732-640-0400, ed@brightcloud.health
About this study
Official title: Telerehabilitation Combining Virtual Reality Adaptable Games and Drug Therapy for Early Alzheimer's Disease - Feasibility
This is a pilot RCT with equal arms: experimental arm and (wait list) control arm.
All participants will be in the early stage of Alzheimer's disease and on stable medication. They will all continue with this medication for their 6 months participation.
Experimental group will add weekly training on the experimental device, 5 days a week for 8 weeks. Training will involve therapeutic games aimed primarily at the memory cognitive domain. All participants will receive weekly calls from clinical coordinator and report on medication and overall health. Caregivers will also be enrolled so they support the trials.
Read the detailed description
Participants will be randomized equally into an experimental group and a wait list control group.
Experimental training will occur in the home, and will last 8 weeks, each week having 5 sessions of therapeutic game play. Each session will start with vitals being measured and logged followed by motor and biosensor baselines. Subsequently, participants will play an increasing number of games, targeted at the major cognitive domains of memory (primarily), attention and executive functions. Since sessions will increase in length, researchers expect that more than 10 short games may eventually be played in each session.
This will be an ABAA protocol for the experimental group, and a AABA protocol for the wait-list control group. Data will be sampled at baseline (A), during each rehabilitation session (B), mid-way through the study (at 2 months from baseline) and at the end of the study, at 4 months from baseline (A).
At the end of every 4 weeks of BrightGo training, the participant and caregiver will each fill a custom subjective evaluation questionnaire.
Before crossover to the experimental protocol, participants in the wait-list group will continue with their daily routine and prescribed medication (which will be logged). After crossing over, they will add the BrightGo intervention to their daily routine.
Participants initially randomized to the experimental group will continue with daily routine and medication, and add the 5 sessions per week of experimental therapy. Once they cross over to the control arm after 8 weeks from start, they will continue with their daily routine and prescribed medication (which will again be logged) for another 8 weeks.
All participants will receive a weekly call from the Clinical Coordinator so to report on any health concerns and system issues, as well as medication use. Caregivers will also be enrolled so they support the trials.
- Conditions
- Alzheimer Disease, Healthy Aging
- Being tested
- BrightGo cognitive training, Standard of Care medication for early Alzheimer's Disease
- Keywords
- Alzheimer's Disease, Virtual Reality, BrightGo, Caregiver, Elderly, Aricept, Exelon
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrightGo cognitive trainingDevice
Also called Gamification for cognitive therapy
Training on the BrightGo experimental device in the home
Standard of Care medication for early Alzheimer's DiseaseDrug
Also called Aricept 10 mg daily or Exelon 9.5 mg patch
Participant takes 10 mg of Aricept daily or wears an Exelon 9.5 mg patch and is stable on one of these medications that were prescribed for diagnostic of early Alzheimer's Disease
| Study group | Role | What they receive |
|---|---|---|
| Standard of care medication for early Alzheimer's disease and BrightGo device cognitive training | Experimental | Participants randomized to the experimental group will have standard of care and 8 weeks of experimental computer-based therapy on the device. Then they will cross over in the control arm. Total participation 4 months during which they will be on Aricept 10 mg daily or Exelon 9.5 mg patch. Receives: Device: BrightGo cognitive training; Drug: Standard of Care medication for early Alzheimer's Disease |
| Standard of care medication for early Alzheimer's disease | Other | Wait list controls will have standard of care only, before they cross over into the experimental group for BrightGo therapy. Total participation 4 months during which they will be on Aricept 10 mg daily or Exelon 9.5 mg patch. Receives: Drug: Standard of Care medication for early Alzheimer's Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual attention as measured by Neuropsychological Assessment Battery
Visual attention measured with the dots test of the Neuropsychological Assessment Battery (NAB). This is a delayed recognition span paradigm, in which an array of dots is exposed for a brief period, followed by a blank interference page, followed by a new array with one additional dot. The subject needs to point to the "new" dot. Test administered 3 times, minimum score 0 (none of the new dots found) to maximum 3 (all 3 new dots found). [Hartman 2006]
Measured: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Controlled Oral Word Change in language and executive function as measured by the Association Test (CFL/PRW) of the Multilingual Aphasia Examination
measure of language and executive function [Benton \& Hamsher, 1994]
Measured: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Change in Cognitive executive function assessment score
Trail Making Test B (TMT-B), NAB Executive Functioning Module. This is a timed test (seconds) with less time indicative of better executive function [Raitan 1958]
Measured: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Change in verbal memory as measured by Hopkins Verbal Learning Test, Revised (HVLT-R)
Hopkins Verbal Learning Test, Revised (HVLT-R) is a measure of verbal memory. It provides a brief assessment of immediate recall, delayed recall and delayed recognition. Subject is read a series of nouns in several categories, and the asked t repeat these nouns by writing them on a piece of paper. The test is repeated three times, and each time the score is a count of how many nouns were remembered by the subject. The second phase of the test involves delayed recall, which is administered after about 20 minutes from the original test. subject needs to write down all the nouns they remembered and these are counted. There is a maximum of 12 correct responses during delayed recall, so max score is 12 [Brandt 1991]
Measured: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Change in visuospatial memory as measured by Brief Visuospatial MemoryTest, Revised (BVMT-R)
BVMT-R is a measure of visuospatial memory. In three Learning Trials, the subject views a stimulus page showing an geometric figure for 10 seconds, and there are 6 drawings presented. Then the subject is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Last, a Recognition Trial, in which the respondent is asked to identify which of 12 figures were included among the original geometric figures, is administered. Raw scores will be used, with higher numbers representing better outcomes [Benedict et al., 1996].
Measured: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Change in Beck Depression Inventory II (BDI II) score, a measure of depression severity
participants' depression measure with higher scores indicating higher severity (worse mood). Score range is 0 to 63, with 0 indicating normal mood (no depression), 1-13 minimal depression, 14-19 mild depression, 20-28 for moderate and 29-63 severe depression.[Beck 1996]
Measured: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Secondary outcomes (14)
Change in the participant's quality of life as measured by the Quality of Life in Alzheimer's Disease Patient Version (QoL-AD)
Questionnaire measures Quality of life for AD individuals (QoL-AD) [Longsdon 1996] The questionnaire has 13 items, each with a 4 possible outcomes (poor 1 point to Excellent 4 points). The score trance is 13 (worst) to 52 points representing the best outcome.
Measured: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Functional Activities Questionnaire in Older Adults with Dementia
Questionnaire for AD patient independence in daily activities [Mayo 2016] The questionnaire has 10 items, each with a 4 possible outcomes (normal 0 points to Dependent 3 points). The score trance is 0 (best outcome) to 30 points representing the worst outcome.
Measured: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Test of Premorbid Functioning (TOPF)
The Advanced Clinical Solutions Test of Premorbid Functioning (TOPF) is a word reading test.
Measured: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Controlled Oral Word Association Test (CFL/PRW) of the Multilingual Aphasia Examination
Test measures Language and executive function [Benton \& Hamsher, 1994] RANGE
Measured: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Categorical verbal fluency (Animal Naming)
Test measures Language and executive function [Tombaugh et al., 1999] RANGE
Measured: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Quality of Life in Alzheimers Disease (QoL-AD), Family Version
The Quality of Life in Alzheimers Disease (QoL-AD) is comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole). Response options include 1(poor), 2(fair), 3(good) and 4 (excellent), for a total score of 13-52, with higher scores indicating better QoL.[Longsdon 1996]. Score range is 13 (worst outcome) to 52 (best outcome).
Measured: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Grasp strength (Jamar dynamometer)
Measure of sustained power grasping force. Three readings on a Jamar dynamometer are averaged. Higher values indicate more abbility to grasp forcefully (a better outcome).
Measured: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Pinch strength (Jamar pinch meter)
Measure of sustained pinch force. Three readings on a Jamar pinch meter are averaged. Higher values indicate more abbility to pinch forcefully (a better outcome).
Measured: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Shoulder strength
Measure of deltoid muscle strength, measured using wrist weights. Higher values indicate more shoulder strength (a better outcome).
Measured: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Arm range of motion (goniometer)
Measure of upper extremity range of motion, measured using a mechanical goniometer. Higher values indicate more arm reach (a better outcome).
Measured: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Jebsen test of hand function
Timed battery of 7 simulated ADLs. Each task is timed with a stop watch, with faster tack execution being a better outcome. Score range for each task is 1 second (best) to 180 seconds (worst - unable to execute task).
Measured: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Chedokee test or independence in bimanual activities (CAHAI-9)
Test has 9 simulated bimanual activities. Each task is scored in the amount of assistance needed to execute it, with a score range for each task of 1 (worst) to 7 (best). Total score range is 9 (worst) to 63 (best).
Measured: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
University of Pennsylvania Smell Identification Test (UPSIT)
This test is a standardized measure of olfactory identification accuracy, done by scratching odor generating special paper. is also a four choice multiple choice question on each page. The scents are released using a pencil. After each scent is released, the patient smells the level and detects the odor from the four choices. Higher score indicate better olfaction (better outcome). Minimum score is 0, Maximum score is 40
Measured: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Subjective evaluation of BrightGo system and therapy
Subjective evaluation on a 5-point Likert scale of system and perceived benefits by participant and by caregiver. The score range is 1 (worst outcome) to 5 (best outcome)
Measured: For experimental group test is at 4, and 8 weeks from baseline. For cross-over controlles test is at 12 and 16 weeks from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start16 Feb 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Pilot RCT. Participants are randomized equally into the experimental group and a wait-list control group. Randomization will be based on a randomization table prepared by a contracted bio-statistician.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bright Cloud International Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), Rutgers, The State University of New Jersey
- Responsible party
- Sponsor
- Investigators
- Grigore C. Burdea, PhD, Principal investigator, Bright Cloud International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732182
- Sponsor's protocol ID
- Telerehab AD Feasibility
- Other IDs
- R43AG065035
- Acronym
- TADF
- Status last verified
- Apr 2022
- First submitted
- 25 Jan 2021
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share individual participant's data
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation Combining Virtual Reality Adaptable Games and Drug Therapy for Early Alzheimer's Disease - Feasibility
- ClinicalTrials.gov ID
- NCT04732182
- Acronym / sponsor ID
- TADF / Telerehab AD Feasibility
- Conditions
- Alzheimer Disease, Healthy Aging
- Keywords
- Alzheimer's Disease, Virtual Reality, BrightGo, Caregiver, Elderly, Aricept, Exelon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Bright Cloud International CorpIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), Rutgers, The State University of New Jersey
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 1 Feb 2021 (actual)
- 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.
This is a pilot RCT with equal arms: experimental arm and (wait list) control arm.
All participants will be in the early stage of Alzheimer's disease and on stable medication. They will all continue with this medication for their 6 months participation.
Experimental group will add weekly training on the experimental device, 5 days a week for 8 weeks. Training will involve therapeutic games aimed primarily at the memory cognitive domain. All participants will receive weekly calls from clinical coordinator and report on medication and overall health. Caregivers will also be enrolled so they support the trials.
Detailed description
Participants will be randomized equally into an experimental group and a wait list control group.
Experimental training will occur in the home, and will last 8 weeks, each week having 5 sessions of therapeutic game play. Each session will start with vitals being measured and logged followed by motor and biosensor baselines. Subsequently, participants will play an increasing number of games, targeted at the major cognitive domains of memory (primarily), attention and executive functions. Since sessions will increase in length, researchers expect that more than 10 short games may eventually be played in each session.
This will be an ABAA protocol for the experimental group, and a AABA protocol for the wait-list control group. Data will be sampled at baseline (A), during each rehabilitation session (B), mid-way through the study (at 2 months from baseline) and at the end of the study, at 4 months from baseline (A).
At the end of every 4 weeks of BrightGo training, the participant and caregiver will each fill a custom subjective evaluation questionnaire.
Before crossover to the experimental protocol, participants in the wait-list group will continue with their daily routine and prescribed medication (which will be logged). After crossing over, they will add the BrightGo intervention to their daily routine.
Participants initially randomized to the experimental group will continue with daily routine and medication, and add the 5 sessions per week of experimental therapy. Once they cross over to the control arm after 8 weeks from start, they will continue with their daily routine and prescribed medication (which will again be logged) for another 8 weeks.
All participants will receive a weekly call from the Clinical Coordinator so to report on any health concerns and system issues, as well as medication use. Caregivers will also be enrolled so they support the trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot RCT. Participants are randomized equally into the experimental group and a wait-list control group. Randomization will be based on a randomization table prepared by a contracted bio-statistician.
| Arm | Type | Receives |
|---|---|---|
| Standard of care medication for early Alzheimer's disease and BrightGo device cognitive training | Experimental | Device: BrightGo cognitive training, Drug: Standard of Care medication for early Alzheimer's DiseaseParticipants randomized to the experimental group will have standard of care and 8 weeks of experimental computer-based therapy on the device. Then they will cross over in the control arm. Total participation 4 months during which they will be on Aricept 10 mg daily or Exelon 9.5 mg patch. |
| Standard of care medication for early Alzheimer's disease | Other | Drug: Standard of Care medication for early Alzheimer's DiseaseWait list controls will have standard of care only, before they cross over into the experimental group for BrightGo therapy. Total participation 4 months during which they will be on Aricept 10 mg daily or Exelon 9.5 mg patch. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Age 65 to 85;
- Diagnosis of early Alzheimer's (Montreal Cognitive Assessment [MoCA] score of 19-25) [Nasreddine et al 2005].
- English speakers;
- Ability to actively move UE and to flex/extend fingers;
- Stable on Aricept 10 mg daily intake or Exelon 9.5 mg patch medication
Key exclusion criteria (14 listed)
- Those younger than 65;
- Participating in other research studies;
- Severe visual impairments or legally blind;
- Severe hearing loss or deafness;
- Uncontrolled hypertension (>190/100 mmHg);
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 |
|---|---|---|
| BrightGo cognitive trainingAlso: Gamification for cognitive therapyTraining on the BrightGo experimental device in the home | Device | Standard of care medication for early Alzheimer's disease and BrightGo device cognitive training |
| Standard of Care medication for early Alzheimer's DiseaseAlso: Aricept 10 mg daily or Exelon 9.5 mg patchParticipant takes 10 mg of Aricept daily or wears an Exelon 9.5 mg patch and is stable on one of these medications that were prescribed for diagnostic of early Alzheimer's Disease | Drug | Standard of care medication for early Alzheimer's disease, Standard of care medication for early Alzheimer's disease and BrightGo device cognitive training |
Primary outcome
Change in visual attention as measured by Neuropsychological Assessment Battery
Time frame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Visual attention measured with the dots test of the Neuropsychological Assessment Battery (NAB). This is a delayed recognition span paradigm, in which an array of dots is exposed for a brief period, followed by a blank interference page, followed by a new array with one additional dot. The subject needs to point to the "new" dot. Test administered 3 times, minimum score 0 (none of the new dots found) to maximum 3 (all 3 new dots found). [Hartman 2006]
Controlled Oral Word Change in language and executive function as measured by the Association Test (CFL/PRW) of the Multilingual Aphasia Examination
Time frame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
measure of language and executive function [Benton \& Hamsher, 1994]
Change in Cognitive executive function assessment score
Time frame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Trail Making Test B (TMT-B), NAB Executive Functioning Module. This is a timed test (seconds) with less time indicative of better executive function [Raitan 1958]
Change in verbal memory as measured by Hopkins Verbal Learning Test, Revised (HVLT-R)
Time frame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Hopkins Verbal Learning Test, Revised (HVLT-R) is a measure of verbal memory. It provides a brief assessment of immediate recall, delayed recall and delayed recognition. Subject is read a series of nouns in several categories, and the asked t repeat these nouns by writing them on a piece of paper. The test is repeated three times, and each time the score is a count of how many nouns were remembered by the subject. The second phase of the test involves delayed recall, which is administered after about 20 minutes from the original test. subject needs to write down all the nouns they remembered and these are counted. There is a maximum of 12 correct responses during delayed recall, so max score is 12 [Brandt 1991]
Change in visuospatial memory as measured by Brief Visuospatial MemoryTest, Revised (BVMT-R)
Time frame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
BVMT-R is a measure of visuospatial memory. In three Learning Trials, the subject views a stimulus page showing an geometric figure for 10 seconds, and there are 6 drawings presented. Then the subject is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Last, a Recognition Trial, in which the respondent is asked to identify which of 12 figures were included among the original geometric figures, is administered. Raw scores will be used, with higher numbers representing better outcomes [Benedict et al., 1996].
Change in Beck Depression Inventory II (BDI II) score, a measure of depression severity
Time frame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
participants' depression measure with higher scores indicating higher severity (worse mood). Score range is 0 to 63, with 0 indicating normal mood (no depression), 1-13 minimal depression, 14-19 mild depression, 20-28 for moderate and 29-63 severe depression.[Beck 1996]
14 secondary outcomes
Change in the participant's quality of life as measured by the Quality of Life in Alzheimer's Disease Patient Version (QoL-AD)
Time frame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Functional Activities Questionnaire in Older Adults with Dementia
Time frame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Test of Premorbid Functioning (TOPF)
Time frame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Controlled Oral Word Association Test (CFL/PRW) of the Multilingual Aphasia Examination
Time frame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Categorical verbal fluency (Animal Naming)
Time frame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Quality of Life in Alzheimers Disease (QoL-AD), Family Version
Time frame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Grasp strength (Jamar dynamometer)
Time frame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Pinch strength (Jamar pinch meter)
Time frame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Shoulder strength
Time frame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Arm range of motion (goniometer)
Time frame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Jebsen test of hand function
Time frame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Chedokee test or independence in bimanual activities (CAHAI-9)
Time frame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
University of Pennsylvania Smell Identification Test (UPSIT)
Time frame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Subjective evaluation of BrightGo system and therapy
Time frame: For experimental group test is at 4, and 8 weeks from baseline. For cross-over controlles test is at 12 and 16 weeks from baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Individual participant dataSharing planned: No. We will not share individual participant's data
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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.
Grigore C. Burdea, PhD principal investigator
Bright Cloud International
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BrightGo cognitive training in people with Alzheimer Disease and Healthy Aging, run by Bright Cloud International Corp at 2 sites in United States.
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 9 inclusion and 14 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 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. 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 Grigore C Burdea, PhD (9084069334, diplomatru@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in visual attention as measured by Neuropsychological Assessment Battery (time frame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 May 2022.