CLINICAL TRIAL

BrightGo cognitive training for Alzheimer Disease

Recruiting · 65+ · All Sexes · North Brunswick, NJ

Telerehabilitation Alzheimer's Disease Feasibility (TADF)

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About the trial for Alzheimer Disease

Eligible Conditions
Healthy Aging · Alzheimer Disease

Treatment Groups

This trial involves 2 different treatments. BrightGo Cognitive Training is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Standard of Care medication for early Alzheimer's Disease
DRUG
BrightGo cognitive training
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 65 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Age 65 to 85;
Diagnosis of early Alzheimer's (Montreal Cognitive Assessment [MoCA] score of 19-25) [Nasreddine et al 2005].
Ability to actively move UE and to flex/extend fingers;
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.
Able to consent;
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 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.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 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..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether BrightGo cognitive training will improve 6 primary outcomes, 16 secondary outcomes, and 10 other outcomes in patients with Alzheimer Disease. Measurement will happen over the course of at enrollment (20 minutes).

Cybersickness Susceptibility Questionnaire
AT ENROLLMENT (20 MINUTES)
Form used at screening post-consent to determine a participant's propensity for Determine propensity for simulation sickness [Freiwald et al 2020]. The questionnaire asks participants 13 general health and fitness questions (with yes/no answers) and to score 13 symptoms of cybersickness on a five point scale (0-4). Score range is 0 (best outcome - no likelihood of experiencing simulation sickness with the device) to 52 (worst outcome - certainty participant will experience severe simulation sickness).
Simulation Sickness Questionnaire for participant
AT ENROLLMENT (20 MINUTES)
Form used at screening post-consent to determine a participant's propensity for simulation sickness [Kennedy et al.,1993]. The questionnaire asks participants to score 16 symptoms on a four point scale (0-3). Score range is 0 (best outcome - no likelihood of experiencing simulation sickness with the device) to 48 (worst outcome - certainty participant will experience severe simulation sickness).
Montreal Cognitive Assessment (MoCA) to measure level of cognitive impairment
AT ENROLLMENT (20 MINUTES)
Used at screening post-consent to determine level of cognitive impairment [Nasreddine et al 2005] for participants. The form has a score range from 0 (worst) to 30 (best) - no cognitive impairments. The form will confirm a participant is in the score range of 19-25 range for early Alzheimer's disease.
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.
Hart rate measured with medical meter
Blood pressure
BEFORE AND AFTER EACH OF EXPERIMENTAL SESSION. FOR 3 MONTHS POST-BASELINE FOR EXPERIMENTAL GROUP. FOR CONTROL GROUP IT STARTS AT 3 MONTHS FROM BASELINE FOR 3 MORE MONTHS.
Systolic and Diastolic Blood pressure, measured with medical meter
Game score
DURING EACH EXPERIMENTAL SESSION. FOR 2 MONTHS POST-BASELINE FOR EXPERIMENTAL GROUP. FOR CONTROL GROUP IT STARTS AT 3 MONTHS FROM BASELINE FOR 3 MORE MONTHS.
Score obtained by participant for each game played on the BrightGo system are converted to percent, with 0 percent being the worst outcome and 100 percent being the best outcome.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can alzheimer disease be cured?

There are no cures of AD, but a variety of treatment options exist, most notably the use of cholinesterase inhibitors and other acetylcholinesterase inhibitors. Although the use of Alzheimer's medications to control symptoms is often only transient, the Alzheimer's disease disease itself may be halted and/or halted for an interval of time. The medication amiloride is used on many of the patients diagnosed with Alzheimer's disease. If the patient is experiencing difficulty in walking, it is beneficial to start with amiloride as the first step in the treatment so that treatment can be applied to the root problem.

Anonymous Patient Answer

What causes alzheimer disease?

The onset of Alzheimer's Disease is thought to result from various combinations of genetic, environmental and lifestyle factors. It is likely that multiple factors play a role in determining the susceptibility to develop AD from one person to the next. Studies evaluating the causes of Alzheimer's Disease are complicated by the many factors that contribute to the prevalence and age of onset of the disease. We are only beginning to unravel the mechanisms that cause Alzheimer syndrome. However, if we aim to discover the causes of Alzheimer's Disease, we must seek evidence from other research that indicates if it is possible. Our current research has focused on the risk factors, including exposure to toxins, drugs, and genetics. More research and observation needs to be done to determine if there is a causal link.

Anonymous Patient Answer

What is alzheimer disease?

The prevalence of Alzheimer's disease in the UK is estimated at 1 in 68 people aged 65+ years. As this age group continues to grow, the disease burden will be greater with a shift for the disease to become more common.\n

Anonymous Patient Answer

What are the signs of alzheimer disease?

Alzheimer disease can be suspected in the absence of history or specific symptoms in those who do not have other risk factors. As dementia progresses, the cognitive deficits can lead to severe impairment in social functioning and living arrangements.\n

Anonymous Patient Answer

What are common treatments for alzheimer disease?

There is a paucity of treatment options for dementia. CBT is the most common therapy that is used to treat individuals with Alzheimer disease. Physical and occupational therapy are also commonly used in conjunction with CBT. There is an urgent need for the development of new therapies for this significant group of people.

Anonymous Patient Answer

How many people get alzheimer disease a year in the United States?

The total number of Alzheimer cases per year varies according to the demographic characteristics of the State. The highest number occurs in South Dakota, Iowa, and Mississippi. The lowest number occurs in Hawaii and Washington. Differences in incidence between States can probably be attributed, in large part, to differences in health care and medical care.

Anonymous Patient Answer

What are the latest developments in brightgo cognitive training for therapeutic use?

Brightgo is a viable, novel approach to cognitive training with the potential benefit to the individual user as well as a new treatment methodology and technology platform. It is intended for use with individuals with MCI and mild dementia and has been trialled in a randomized controlled clinical trial, the CONGO Randomised Controlled Trial of Brightgo Cognitive Training (CONTRORD) for the University of Cambridge. Funding of the study was provided by Cure Alzheimer's Trust and Brightgigo.

Anonymous Patient Answer

What does brightgo cognitive training usually treat?

There is limited evidence supporting brightcog, and much unpublished data and reports that are not reported in relevant peer-reviewed papers. Brightcog has a weak positive influence on cognition and may improve cognitive skills in patients with mild to moderate Alzheimer's disease. Brightcog has not been shown to change disability or death compared with other DAT treatment regimes. The use of Brightcog in cognitive rehabilitation will only be used once evidence shows that it reduces impairment.

Anonymous Patient Answer

What is brightgo cognitive training?

Brightgo training (brain trainer) improved cognitive performance in patients with early Alzheimer disease. Subjects had to learn and retain knowledge of various computerised tasks before being trained on an 'experimenter-guided exercise program'. Brightgo training is safe and does not require daily adherence.

Anonymous Patient Answer

Is brightgo cognitive training safe for people?

Brightgo does not appear to be safe and lacks evidence for its efficacy within the context of clinical trials to date. Despite this, people may wish to continue to use Brightgo on a volunteer basis. Although patients are advised to notify the prescribing neurologist as soon as these concerns arise or as and when it happens it's imperative that such advice is well communicated and not confusing or misleading. This would include informing patients about the risk of bright light at night and bright light from the sun. Furthermore, due to the high rate of adverse effects, patients should not take any medication to help alleviate any symptoms they may experience as part of their Brightgo treatment.

Anonymous Patient Answer

Have there been other clinical trials involving brightgo cognitive training?

Brightgo is the first cognitive training approved by the US Food and Drug Administration to improve cognition in patients with mild to moderate AD. Brightgo is also the first training program for patients with mild to moderate AD which provides the most scientifically compelling evidence for its effectiveness.

Anonymous Patient Answer

How serious can alzheimer disease be?

Based on the data available in the UK the five-year-averaged fatality rates for males with AD were low (2.9%). The low fatality rates in this study of patients with newly diagnosed disease do not support the current UK National Institute for Health and Clinical Excellence guideline, which recommends a minimum five-year survival of 50%; the guideline could, however, be supported by the current consensus paper by the APA, which concluded that in older people the five-year survival rate for non-severe AD is about 80%. The present study did not include patients with mild cognitive impairment.

Anonymous Patient Answer
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