Recruiting

Telerehabilitation

Sponsor:

Bright Cloud International Corp

Code:

NCT04732182

Conditions

Alzheimer Disease

Healthy Aging

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

Interventions

BrightGo cognitive training

Standard of Care medication for early Alzheimer's Disease

Study Details

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

Study ID

NCT04732182

Start date

Feb 16, 2022

Status verified date

Apr, 2022

Completion date

Feb 28, 2023

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

14 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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.

other: Standard of care medication for early Alzheimer's disease

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.

Interventions

BrightGo cognitive training

Training on the BrightGo experimental device in the home

Standard of Care medication for early Alzheimer's Disease

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

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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Grigore C Burdea, PhD

9084069334diplomatru@yahoo.com

Edward A Berde, MS

7326400400ed@brightcloud.health

Locations

Rutgers, The State University of New Jersey

Recruiting

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

Contacts

Jasdeep S Hundal, PsyD

732-235-6332jsh164@rwjms.rutgers.edu

Daniel Valdivia, B.S.

2013164424djv85@gsbs.rutgers.edu

Principal Investigator:

Jasdeep S Hundal, PsyD

Bright Cloud Int'l Corp

Recruiting

North Brunswick, New Jersey, United States, 08902

Contacts

Grigore C Burdea, PhD

908-406-9334diplomatru@yahoo.com

Edward A Berde, MS

732-640-0400ed@brightcloud.health

Principal Investigator:

Grigore C Burdea, PhD

More Information

Sponsor

Bright Cloud International Corp

Last update posted

May 2, 2022

Last verified

Apr, 2022

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bright Cloud International Corp on 2022-05-02.