Online Neuropsychological Test Validation Project With Imaging Pilot

NCT02486250 | Completed

• 1 other identifier: 13-12765
• Study Type: observational
• Target: 982
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Validation of Online Cognitive Testing

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Secondary Outcomes (1)

• Difference between unsupervised cognitive test score vs. supervised cognitive test score

  3 years

Other Outcomes (2)

• Number of online recruited participants who successfully complete imaging component

  1 year

• Participants performance on ReVeRe test battery

  3 years

Study Arms (4)

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.

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.

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.

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.

Interventions

Validation Study OTHER

MRI & PET Substudy; Main Study Recruits; ReVeRe 1

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Adults age 60 years and older * Fluent in English * Able to give informed consent * Access and the ability to use the internet

You may qualify if:

• Adults age 60 years and older
• Fluent in English
• Able to give informed consent
• Access and the ability to use the internet

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Johnson & Johnson: collaborator
• Avid Radiopharmaceuticals: collaborator

Study Sites (1)

BrainHealthRegistry.org

San Francisco, California, 94121, United States

Location

Related Links

• This is the website for the Brain Health Registry.

Study Officials

• Michael Weiner, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2015
• First Posted: July 1, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: March 1, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

US (1)