Longitudinal Cognitive Assessment by BoCA

• Sponsor: Alzheimer's Light LLC (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04114994
• Collaborator: (none)
• Enrollment: 10,000
• Location: 1
• Anticipated Duration (Months): 120
• Patients Per Site Per Month: 83.3

Study Details

Study Description

Brief Summary

The Boston Cognitive Assessment (BoCA) is a self-administered online test intended for longitudinal cognitive monitoring. BoCA uses random not-repeating tasks to minimize learning effects. BoCA was developed to evaluate the effects of treatment in longitudinal clinical trials and available gratis to individuals and professionals.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease; Mild Cognitive Impairment; Vascular Dementia; Frontotemporal Dementia; Parkinson Disease; Multiple Sclerosis; TBI	Diagnostic Test: Boston Cognitive Assessment (BoCA)

Detailed Description

The Boston Cognitive Assessment (BoCA) is a self-administered online test intended for longitudinal cognitive monitoring. BoCA uses random not- repeating tasks to minimize learning effects. BoCA was developed to evaluate the effects of treatment in longitudinal clinical trials and available gratis to individuals and professionals.

BoCA includes eight subtests in the following domains: Memory/Immediate Recall, Memory/Delayed Recall, Executive function/ Visuospatial, Executive function/ Mental rotation, Attention, Mental math, Language/Prefrontal Synthesis, and Orientation. The maximum total score is 30. Higher score indicates better cognitive performance.

After BoCA is completed, the domain scores and total score are provided immediately. Users will also receive an email with the link to the full report with progress charts.

The BoCA evaluation can help doctors figure out if an underlying condition is causing a patient's cognitive decline. Many treatable conditions such as sleep disorders, mood problems, heavy metal accumulation, as well as lack of movement and social interactions can affect memory and thinking.

Our goal is to reduce barriers for patients to receive the testing that may benefit their treatment and health through the use of digital technology.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 10000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Longitudinal Cognitive Assessment by BoCA
• Actual Study Start Date: Oct 1, 2019
• Anticipated Primary Completion Date: Oct 1, 2029
• Anticipated Study Completion Date: Oct 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Alzheimer's Disease	Diagnostic Test: Boston Cognitive Assessment (BoCA); The Boston Cognitive Assessment (BoCA) is a self-administered online test intended for longitudinal cognitive monitoring. BoCA uses random not-repeating tasks to minimize learning effects. BoCA was developed to evaluate the effects of treatment in longitudinal clinical trials and available gratis to individuals and professionals. BoCA includes eight subtests in the following domains: Memory/Immediate Recall, Memory/Delayed Recall, Executive function/ Visuospatial, Executive function/ Mental rotation, Attention, Mental math, Language/Prefrontal Synthesis, and Orientation. The maximum total score is 30. Higher score indicates better cognitive performance. After BoCA is completed, the domain scores and total score are provided immediately. Users will also receive an email with the link to the full report with progress charts.
Mild Cognitive Impairment	Diagnostic Test: Boston Cognitive Assessment (BoCA); The Boston Cognitive Assessment (BoCA) is a self-administered online test intended for longitudinal cognitive monitoring. BoCA uses random not-repeating tasks to minimize learning effects. BoCA was developed to evaluate the effects of treatment in longitudinal clinical trials and available gratis to individuals and professionals. BoCA includes eight subtests in the following domains: Memory/Immediate Recall, Memory/Delayed Recall, Executive function/ Visuospatial, Executive function/ Mental rotation, Attention, Mental math, Language/Prefrontal Synthesis, and Orientation. The maximum total score is 30. Higher score indicates better cognitive performance. After BoCA is completed, the domain scores and total score are provided immediately. Users will also receive an email with the link to the full report with progress charts.
Frontotemporal Dementia	Diagnostic Test: Boston Cognitive Assessment (BoCA); The Boston Cognitive Assessment (BoCA) is a self-administered online test intended for longitudinal cognitive monitoring. BoCA uses random not-repeating tasks to minimize learning effects. BoCA was developed to evaluate the effects of treatment in longitudinal clinical trials and available gratis to individuals and professionals. BoCA includes eight subtests in the following domains: Memory/Immediate Recall, Memory/Delayed Recall, Executive function/ Visuospatial, Executive function/ Mental rotation, Attention, Mental math, Language/Prefrontal Synthesis, and Orientation. The maximum total score is 30. Higher score indicates better cognitive performance. After BoCA is completed, the domain scores and total score are provided immediately. Users will also receive an email with the link to the full report with progress charts.
Vascular Dementia	Diagnostic Test: Boston Cognitive Assessment (BoCA); The Boston Cognitive Assessment (BoCA) is a self-administered online test intended for longitudinal cognitive monitoring. BoCA uses random not-repeating tasks to minimize learning effects. BoCA was developed to evaluate the effects of treatment in longitudinal clinical trials and available gratis to individuals and professionals. BoCA includes eight subtests in the following domains: Memory/Immediate Recall, Memory/Delayed Recall, Executive function/ Visuospatial, Executive function/ Mental rotation, Attention, Mental math, Language/Prefrontal Synthesis, and Orientation. The maximum total score is 30. Higher score indicates better cognitive performance. After BoCA is completed, the domain scores and total score are provided immediately. Users will also receive an email with the link to the full report with progress charts.
Parkinson Disease	Diagnostic Test: Boston Cognitive Assessment (BoCA); The Boston Cognitive Assessment (BoCA) is a self-administered online test intended for longitudinal cognitive monitoring. BoCA uses random not-repeating tasks to minimize learning effects. BoCA was developed to evaluate the effects of treatment in longitudinal clinical trials and available gratis to individuals and professionals. BoCA includes eight subtests in the following domains: Memory/Immediate Recall, Memory/Delayed Recall, Executive function/ Visuospatial, Executive function/ Mental rotation, Attention, Mental math, Language/Prefrontal Synthesis, and Orientation. The maximum total score is 30. Higher score indicates better cognitive performance. After BoCA is completed, the domain scores and total score are provided immediately. Users will also receive an email with the link to the full report with progress charts.
Traumatic Brain Injury (TBI)	Diagnostic Test: Boston Cognitive Assessment (BoCA); The Boston Cognitive Assessment (BoCA) is a self-administered online test intended for longitudinal cognitive monitoring. BoCA uses random not-repeating tasks to minimize learning effects. BoCA was developed to evaluate the effects of treatment in longitudinal clinical trials and available gratis to individuals and professionals. BoCA includes eight subtests in the following domains: Memory/Immediate Recall, Memory/Delayed Recall, Executive function/ Visuospatial, Executive function/ Mental rotation, Attention, Mental math, Language/Prefrontal Synthesis, and Orientation. The maximum total score is 30. Higher score indicates better cognitive performance. After BoCA is completed, the domain scores and total score are provided immediately. Users will also receive an email with the link to the full report with progress charts.
Multiple Sclerosis	Diagnostic Test: Boston Cognitive Assessment (BoCA); The Boston Cognitive Assessment (BoCA) is a self-administered online test intended for longitudinal cognitive monitoring. BoCA uses random not-repeating tasks to minimize learning effects. BoCA was developed to evaluate the effects of treatment in longitudinal clinical trials and available gratis to individuals and professionals. BoCA includes eight subtests in the following domains: Memory/Immediate Recall, Memory/Delayed Recall, Executive function/ Visuospatial, Executive function/ Mental rotation, Attention, Mental math, Language/Prefrontal Synthesis, and Orientation. The maximum total score is 30. Higher score indicates better cognitive performance. After BoCA is completed, the domain scores and total score are provided immediately. Users will also receive an email with the link to the full report with progress charts.
No diagnosis	Diagnostic Test: Boston Cognitive Assessment (BoCA); The Boston Cognitive Assessment (BoCA) is a self-administered online test intended for longitudinal cognitive monitoring. BoCA uses random not-repeating tasks to minimize learning effects. BoCA was developed to evaluate the effects of treatment in longitudinal clinical trials and available gratis to individuals and professionals. BoCA includes eight subtests in the following domains: Memory/Immediate Recall, Memory/Delayed Recall, Executive function/ Visuospatial, Executive function/ Mental rotation, Attention, Mental math, Language/Prefrontal Synthesis, and Orientation. The maximum total score is 30. Higher score indicates better cognitive performance. After BoCA is completed, the domain scores and total score are provided immediately. Users will also receive an email with the link to the full report with progress charts.

Outcome Measures

Primary Outcome Measures

1. Boston Cognitive Assessment (BoCA) [through study completion, an average of 1 year]

   The Boston Cognitive Assessment (BoCA) is a self-administered online test intended for longitudinal cognitive monitoring. BoCA uses random not-repeating tasks to minimize learning effects. BoCA was developed to evaluate the effects of treatment in longitudinal clinical trials and available gratis to individuals and professionals.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

age 50 or older

Exclusion Criteria:

younger than 50 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Andrey Vyshedskiy	Miami	Florida	United States	33156

Sponsors and Collaborators

• Alzheimer's Light LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BoCA website

Publications

• Foster NL, Bondi MW, Das R, Foss M, Hershey LA, Koh S, Logan R, Poole C, Shega JW, Sood A, Thothala N, Wicklund M, Yu M, Bennett A, Wang D. Quality improvement in neurology: Mild cognitive impairment quality measurement set. Neurology. 2019 Oct 15;93(16):705-713. doi: 10.1212/WNL.0000000000008259. Epub 2019 Sep 18. Review.

• Responsible Party: Alzheimer's Light LLC
• ClinicalTrials.gov Identifier: NCT04114994
• Other Study ID Numbers: BoCA001
• First Posted: Oct 3, 2019
• Last Update Posted: Jul 20, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Parkinson Disease; Multiple Sclerosis; Alzheimer Disease; Dementia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain; Dementia, Vascular; Cognitive Dysfunction

Study Results

No Results Posted as of Jul 20, 2021