Telerehabilitation Alzheimer's Disease Feasibility (TADF)

NCT04732182 | Unknown DMC

• 2 other identifiers: Telerehab AD FeasibilityR43AG065035
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Alzheimer Disease; Healthy Aging

Keywords

Alzheimer's Disease; Virtual Reality; BrightGo; Caregiver; Elderly; Aricept; Exelon

Outcome Measures

Primary Outcomes (6)

• 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). \[Hartman 2006\]

  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 \[Benton \& Hamsher, 1994\]

  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 \[Raitan 1958\]

  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 \[Brandt 1991\]

  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 \[Benedict et al., 1996\].

  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.\[Beck 1996\]

  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)

  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

  at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)

• Test of Premorbid Functioning (TOPF)

  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

  at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)

• Categorical verbal fluency (Animal Naming)

  at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)

Other Outcomes (9)

• Cybersickness Susceptibility Questionnaire

  at enrollment (20 minutes)

• Montreal Cognitive Assessment (MoCA) to measure level of cognitive impairment

  at enrollment (20 minutes)

• Pulse

  Before and after each of experimental session. For 3 months post-baseline for experimental group, or starting at 3 months from baseline for controll group. After cross over control group will take pulse for 3 months.

Study Arms (2)

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.

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.

Drug: Standard of Care medication for early Alzheimer's Disease

Interventions

BrightGo cognitive training DEVICE

Training on the BrightGo experimental device in the home

Also known as: Gamification for cognitive therapy

Standard of care medication for early Alzheimer's disease and BrightGo device cognitive training

Standard of Care medication for early Alzheimer's Disease DRUG

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

Also known as: Aricept 10 mg daily or Exelon 9.5 mg patch

Standard of care medication for early Alzheimer's disease; Standard of care medication for early Alzheimer's disease and BrightGo device cognitive training

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Bright Cloud International Corp: lead
• National Institute on Aging (NIA): collaborator
• Rutgers, The State University of New Jersey: collaborator

Study Sites (2)

Rutgers, The State University of New Jersey

New Brunswick, New Jersey, 08901-2066, United States

RECRUITING

Bright Cloud Int'l Corp

North Brunswick, New Jersey, 08902, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Donepezil; Rivastigmine; Transdermal Patch

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Phenylcarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Equipment and Supplies

Study Officials

• Grigore C. Burdea, PhD

  Bright Cloud International

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grigore C Burdea, PhD

CONTACT

9084069334; diplomatru@yahoo.com

Edward A Berde, MS

CONTACT

7326400400; ed@brightcloud.health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor will not be told which group the participant is part of, so not be biased in evaluations.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 1, 2021
• Study Start: February 16, 2022
• Primary Completion: December 31, 2022
• Study Completion: February 28, 2023
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)