Validation of Online Cognitive TestingNVPNCT02486250
Online Neuropsychological Test Validation Project With Imaging Pilot
An observational study of Validation of Online Cognitive Testing, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a five year study conducted in cooperation with the Brain Health Registry (BHR), an internet-based registry which enrolls adult volunteers in order to facilitate clinical trials for the prevention of Alzheimer's disease (AD). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Validation of Online Cognitive Testing
- What is being tested?
- Validation Study
- How many people
- 982 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Mar 2021
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Adults age 60 years and older * Fluent in English * Able to give informed consent * Access and the ability to use the internet
Who may be able to join
- Adults age 60 years and older
- Fluent in English
- Able to give informed consent
- Access and the ability to use the internet
Who cannot join
- Evidence or diagnosis of dementia
- Evidence of acute or uncontrolled medical illness
- Recent history (< 6 months) of abuse or dependence of drugs and/or alcohol
- Significant neurological disease (ex. Parkinson's disease, Epilepsy, Traumatic brain injury)
- Additionally, subjects participating in the neuroimaging portion of the study, will be excluded for any of the following:
- Unable or unwilling to travel to SFVAMC and UCSF China Basin campuses for MRI and PET procedures
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- Contraindications for MR exam, including claustrophobia, paramagnetic metal implants, inability to fit comfortably in MRI (BMI < 38)
- Clinically significant hepatic, renal, pulmonary, metabolic or endocrine disturbances as indicated by history which in the opinion of the Investigator might pose a potential safety risk to the subject
- Current clinically significant cardiovascular disease. Clinically significant cardiovascular disease usually includes one or more of the following:
- Cardiac surgery or myocardial infarction within the last 4 weeks
- Unstable angina
- Acute decompensated congestive heart failure or class IV heart failure
- Current significant cardiac arrhythmia or conduction disturbance, particularly those resulting in ventricular fibrillation, or causing syncope, or near syncope
- Uncontrolled high blood pressure
- QTc > 450 msec
- History of drug or alcohol abuse within the last year, or prior prolonged history of abuse
- Women of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. Women of childbearing potential must not be pregnant or breastfeeding at screening.
- History of relevant severe drug allergy or hypersensitivity.
- Receiving an investigational medication under an FDA IND protocol within the last 30 days. Additionally, the time between the last dose of the previous experimental medication and enrollment (completion of screening assessments) must be at least equal to 5 times the terminal half-life of the previous experimental medication. Subjects who have ever participated in an experimental study with an amyloid targeting therapy (e.g., immunotherapy, secretase inhibitor) may not be enrolled without prior sponsor approval unless it can be demonstrated that the patient received only placebo in the course of the trial.
- Current clinically significant unstable medical comorbidities, as indicated by history that pose a potential safety risk to the subject
- Receiving a radiopharmaceutical for imaging or therapy within the past 24 hours prior to the imaging session for this study
- Opinion of the Investigator that the subject is otherwise an unsuitable for study
Trial locations and contacts
1 site in 1 country.
United States1 site
BrainHealthRegistry.org
San Francisco, California, 94121
About this study
This is a five year study conducted in cooperation with the Brain Health Registry (BHR), an internet-based registry which enrolls adult volunteers in order to facilitate clinical trials for the prevention of Alzheimer's disease (AD). The investigators goal is to validate the Brain Health Registry's online cognitive measures developed by Lumosity. Investigators will meet this goal by collecting data from the newly developed the BHR online cognitive screening battery along with standardized measures of memory, attention, executive functioning and speed of information processing currently used in clinical trials for Alzheimer's disease.
Read the detailed description
This study is conducted in cooperation with the Brain Health Registry (BHR, CHR #12-09628), an internet-based registry which will enroll individuals in order to facilitate clinical trials for the prevention of Alzheimer's disease (AD) and other brain diseases and disorders.
The investigators goal is to validate the Brain Health Registry's online cognitive measures developed by Lumosity. Investigators will meet this goal by collecting data from the newly developed BHR online cognitive screening battery along with standardized measures of memory, attention, executive functioning and speed of information processing currently used in clinical trials for Alzheimer's disease.
Investigators will enroll 1000 subjects, 500 of whom will be recruited upon registering in the BHR. The other 500 subjects will be recruited from the Memory and Aging Center at the University of California, San Francisco (UCSF) and the Center for Imaging of Neurodegenerative Diseases (CIND) at the San Francisco VA Medical Center (SFVAMC). Demographic and clinical data will be obtained for each participant who will have 3 tests of cognitive function over a 2 week period: 1) unsupervised online cognitive testing, 2) supervised online cognitive testing, and 3) standard clinical neuropsychological assessments. The order in which cognitive evaluations are administered will be equally distributed within the sample so as to minimize practice effects. These subjects will also provide a saliva specimen in order to determine their ApoE genotype.
Additionally, investigators will also conduct a small pilot study of 34 subjects to obtain one 3 Tesla MRI scan and one PET scan in order to obtain feasibility data for collecting longitudinal neuroimaging studies for participants in this sample.
In addition to the main validation project and MRI/PET substudy, we will also run a substudy (n=330) that looks to validate an additional unsupervised online cognitive measure (administered via iPad application) called ReVeRe. ReVeRe, is an automated, self-administered measure of verbal memory (word list recall) that is modeled after the Rey Auditory Verbal Learning Test.
There are two substudies for ReVeRe:
ReVeRe 1 (n=250): This approximately 30 minute procedure will be administered initially during the NVP participant's clinic visit, and then will be collected remotely (by participants at home) on: (1) Day 7 after the initial clinic testing, (2) Day 21 after the initial clinic testing, and (3) ongoing at 6 month intervals through at least 18 months - for a total of 6 administrations.
ReVeRe 2 (n=80): This approximately 30 minute procedure will be administered initially 2 weeks after a follow up in-clinic visit, and then will be collected remotely in burst intervals. There will be three administrations at each time point (Day 0, 3, and 7), which will be collected every 6 months for 24 months after the in-clinic follow up visit. All participants in ReVeRe 2 will also receive an amyloid PET scan, as long as they did not already participate in the MRI/PET substudy.
- Conditions
- Validation of Online Cognitive Testing
- Being tested
- Validation Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validation StudyOther
| Study group | Role | What they receive |
|---|---|---|
| Main Study Recruits | Participants are recruited to come into a clinic and take supervised cognitive tests both online and paper/pencil as well as take unsupervised online cognitive tests at home. Participants will also be given a spit kit in clinic to determine ApOE Status. Receives: Other: Validation Study | |
| MRI & PET Substudy | A subset of 34 participants from the Main Study Recruits will be invited to have an MRI and PET scan. The purpose of the sub-study is to obtain feasibility data for collecting longitudinal neuroimaging studies for participants in this sample. Receives: Other: Validation Study | |
| ReVeRe 1 | A subset of 250 participants from the Main Study Recruits and all MRI \& PET Substudy participants will be invited to participate in ReVeRe 1. The purpose of ReVeRe is to validate an additional unsupervised online cognitive measure, administered via an iPad application. Receives: Other: Validation Study | |
| ReVeRe 2 | A subset of approximately 80 participants from the Main Study Recruits and MRI \& PET Substudy participants will be invited to participate in ReVeRe 2. The purpose of ReVeRe 2 is to determine if performance on ReVeRe test battery is sensitive to amyloid positivity in cognitively intact older adults and also sensitive to longitudinal cognitive decline in this patient population. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of people recruited online for in-clinic study
Number of people recruited online for in-clinic study will help determine the feasibility of using the Brain Health Registry as a recruitment source for an in-clinic study at the SFVAMC.
Measured: 3 years
Secondary outcomes (1)
Difference between unsupervised cognitive test score vs. supervised cognitive test score
A primary goal of this study is to validate the unsupervised online cognitive screening battery with the supervised cognitive test score. We will meet this goal by collecting data from the newly developed BHR online cognitive screening battery along with standardized measures of memory, attention, executive functioning and speed of information processing currently used in clinical trials for Alzheimer's disease.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2017
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Validation of Online Cognitive TestingStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- 982 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson, Avid Radiopharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Michael Weiner, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486250
- Sponsor's protocol ID
- 13-12765
- Acronym
- NVP
- Status last verified
- Mar 2021
- First submitted
- 18 Jun 2015
- Last updated
- 1 Apr 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Neuropsychological Test Validation Project With Imaging Pilot
- ClinicalTrials.gov ID
- NCT02486250
- Acronym / sponsor ID
- NVP / 13-12765
- Conditions
- Validation of Online Cognitive Testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 982 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Johnson & Johnson, Avid Radiopharmaceuticals
- Study start
- Jan 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 1 Jul 2015 (estimated)
- 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.
This is a five year study conducted in cooperation with the Brain Health Registry (BHR), an internet-based registry which enrolls adult volunteers in order to facilitate clinical trials for the prevention of Alzheimer's disease (AD). The investigators goal is to validate the Brain Health Registry's online cognitive measures developed by Lumosity. Investigators will meet this goal by collecting data from the newly developed the BHR online cognitive screening battery along with standardized measures of memory, attention, executive functioning and speed of information processing currently used in clinical trials for Alzheimer's disease.
Detailed description
This study is conducted in cooperation with the Brain Health Registry (BHR, CHR #12-09628), an internet-based registry which will enroll individuals in order to facilitate clinical trials for the prevention of Alzheimer's disease (AD) and other brain diseases and disorders.
The investigators goal is to validate the Brain Health Registry's online cognitive measures developed by Lumosity. Investigators will meet this goal by collecting data from the newly developed BHR online cognitive screening battery along with standardized measures of memory, attention, executive functioning and speed of information processing currently used in clinical trials for Alzheimer's disease.
Investigators will enroll 1000 subjects, 500 of whom will be recruited upon registering in the BHR. The other 500 subjects will be recruited from the Memory and Aging Center at the University of California, San Francisco (UCSF) and the Center for Imaging of Neurodegenerative Diseases (CIND) at the San Francisco VA Medical Center (SFVAMC). Demographic and clinical data will be obtained for each participant who will have 3 tests of cognitive function over a 2 week period: 1) unsupervised online cognitive testing, 2) supervised online cognitive testing, and 3) standard clinical neuropsychological assessments. The order in which cognitive evaluations are administered will be equally distributed within the sample so as to minimize practice effects. These subjects will also provide a saliva specimen in order to determine their ApoE genotype.
Additionally, investigators will also conduct a small pilot study of 34 subjects to obtain one 3 Tesla MRI scan and one PET scan in order to obtain feasibility data for collecting longitudinal neuroimaging studies for participants in this sample.
In addition to the main validation project and MRI/PET substudy, we will also run a substudy (n=330) that looks to validate an additional unsupervised online cognitive measure (administered via iPad application) called ReVeRe. ReVeRe, is an automated, self-administered measure of verbal memory (word list recall) that is modeled after the Rey Auditory Verbal Learning Test.
There are two substudies for ReVeRe:
ReVeRe 1 (n=250): This approximately 30 minute procedure will be administered initially during the NVP participant's clinic visit, and then will be collected remotely (by participants at home) on: (1) Day 7 after the initial clinic testing, (2) Day 21 after the initial clinic testing, and (3) ongoing at 6 month intervals through at least 18 months - for a total of 6 administrations.
ReVeRe 2 (n=80): This approximately 30 minute procedure will be administered initially 2 weeks after a follow up in-clinic visit, and then will be collected remotely in burst intervals. There will be three administrations at each time point (Day 0, 3, and 7), which will be collected every 6 months for 24 months after the in-clinic follow up visit. All participants in ReVeRe 2 will also receive an amyloid PET scan, as long as they did not already participate in the MRI/PET substudy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Main Study Recruits | – | Other: Validation StudyParticipants are recruited to come into a clinic and take supervised cognitive tests both online and paper/pencil as well as take unsupervised online cognitive tests at home. Participants will also be given a spit kit in clinic to determine ApOE Status. |
| MRI & PET Substudy | – | Other: Validation StudyA subset of 34 participants from the Main Study Recruits will be invited to have an MRI and PET scan. The purpose of the sub-study is to obtain feasibility data for collecting longitudinal neuroimaging studies for participants in this sample. |
| ReVeRe 1 | – | Other: Validation StudyA subset of 250 participants from the Main Study Recruits and all MRI \& PET Substudy participants will be invited to participate in ReVeRe 1. The purpose of ReVeRe is to validate an additional unsupervised online cognitive measure, administered via an iPad application. |
| ReVeRe 2 | – | –A subset of approximately 80 participants from the Main Study Recruits and MRI \& PET Substudy participants will be invited to participate in ReVeRe 2. The purpose of ReVeRe 2 is to determine if performance on ReVeRe test battery is sensitive to amyloid positivity in cognitively intact older adults and also sensitive to longitudinal cognitive decline in this patient population. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Adults age 60 years and older * Fluent in English * Able to give informed consent * Access and the ability to use the internet
Key inclusion criteria (4 listed)
- Adults age 60 years and older
- Fluent in English
- Able to give informed consent
- Access and the ability to use the internet
Key exclusion criteria (22 listed)
- Evidence or diagnosis of dementia
- Evidence of acute or uncontrolled medical illness
- Recent history (< 6 months) of abuse or dependence of drugs and/or alcohol
- Significant neurological disease (ex. Parkinson's disease, Epilepsy, Traumatic brain injury)
- Additionally, subjects participating in the neuroimaging portion of the study, will be excluded for any of the following:
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 |
|---|---|---|
| Validation Study | Other | MRI & PET Substudy, Main Study Recruits, ReVeRe 1 |
Primary outcome
Number of people recruited online for in-clinic study
Time frame: 3 years
Number of people recruited online for in-clinic study will help determine the feasibility of using the Brain Health Registry as a recruitment source for an in-clinic study at the SFVAMC.
1 secondary outcome
Difference between unsupervised cognitive test score vs. supervised cognitive test score
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- This is the website for the Brain Health Registry.Link provided by the sponsor.
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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. This study is not recruiting at the moment.
Michael Weiner, MD principal investigator
University of California, San Francisco
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 Validation of Online Cognitive Testing, run by University of California, San Francisco 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 4 inclusion and 22 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: finished, as of the sponsor's last update on 1 Apr 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of people recruited online for in-clinic study (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2021.