Alzheimer DiseaseBoCANCT04114994
Longitudinal Cognitive Assessment by BoCA
An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by Alzheimer's Light LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment, Vascular Dementia
- What is being tested?
- Boston Cognitive Assessment (BoCA)
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 1 Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: According to the American Academy of Neurology, nearly 7% of people in their early 60s worldwide have mild cognitive impairment, while the condition affects 38% of people ages 85 and older. 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.
Who may be able to join
- age 50 or older
Who cannot join
- younger than 50 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Andrey Vyshedskiy
Miami, Florida, 33156
Andrey Vyshedskiy, 617-433-8577, vysha@bu.edu
About this study
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.
Read the 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.
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Vascular Dementia, Frontotemporal Dementia, Parkinson Disease, Multiple Sclerosis
- Being tested
- Boston Cognitive Assessment (BoCA)
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia, Vascular, Frontotemporal Dementia, Parkinson Disease, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boston Cognitive Assessment (BoCA)Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's Disease | Not described Receives: Diagnostic Test: Boston Cognitive Assessment (BoCA) | |
| Mild Cognitive Impairment | Not described Receives: Diagnostic Test: Boston Cognitive Assessment (BoCA) | |
| Frontotemporal Dementia | Not described Receives: Diagnostic Test: Boston Cognitive Assessment (BoCA) | |
| Vascular Dementia | Not described Receives: Diagnostic Test: Boston Cognitive Assessment (BoCA) | |
| Parkinson Disease | Not described Receives: Diagnostic Test: Boston Cognitive Assessment (BoCA) | |
| Traumatic Brain Injury (TBI) | Not described Receives: Diagnostic Test: Boston Cognitive Assessment (BoCA) | |
| Multiple Sclerosis | Not described Receives: Diagnostic Test: Boston Cognitive Assessment (BoCA) | |
| No diagnosis | Not described Receives: Diagnostic Test: Boston Cognitive Assessment (BoCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start1 Oct 2019
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alzheimer's Light LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114994
- Sponsor's protocol ID
- BoCA001
- Acronym
- BoCA
- Status last verified
- Jul 2024
- First submitted
- 2 Oct 2019
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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. No abstract available.
PubMed 31534026
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Cognitive Assessment by BoCA
- ClinicalTrials.gov ID
- NCT04114994
- Acronym / sponsor ID
- BoCA / BoCA001
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Vascular Dementia, Frontotemporal Dementia, Parkinson Disease, Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Alzheimer's Light LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 3 Oct 2019 (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.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's Disease | – | Diagnostic Test: Boston Cognitive Assessment (BoCA) |
| Mild Cognitive Impairment | – | Diagnostic Test: Boston Cognitive Assessment (BoCA) |
| Frontotemporal Dementia | – | Diagnostic Test: Boston Cognitive Assessment (BoCA) |
| Vascular Dementia | – | Diagnostic Test: Boston Cognitive Assessment (BoCA) |
| Parkinson Disease | – | Diagnostic Test: Boston Cognitive Assessment (BoCA) |
| Traumatic Brain Injury (TBI) | – | Diagnostic Test: Boston Cognitive Assessment (BoCA) |
| Multiple Sclerosis | – | Diagnostic Test: Boston Cognitive Assessment (BoCA) |
| No diagnosis | – | Diagnostic Test: Boston Cognitive Assessment (BoCA) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- According to the American Academy of Neurology, nearly 7% of people in their early 60s worldwide have mild cognitive impairment, while the condition affects 38% of people ages 85 and older. 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.
Key inclusion criteria (1 listed)
- age 50 or older
Key exclusion criteria (1 listed)
- younger than 50 years
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 |
|---|---|---|
| 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. | Diagnostic test | Alzheimer's Disease, Frontotemporal Dementia, Mild Cognitive Impairment, Multiple Sclerosis, No diagnosis, Parkinson Disease, Traumatic Brain Injury (TBI), Vascular Dementia |
Primary outcome
Boston Cognitive Assessment (BoCA)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Background: PubMed 31534026Foster 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. No abstract available.
- BoCA websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by Alzheimer's Light LLC at 1 site 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ANDREY VYSHEDSKIY, Ph.D. (6174338577, vysha@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Cognitive Assessment (BoCA) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04114994, which also lists 1 linked publication.
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 1 Aug 2024.