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Brain Health Registry (BHR)

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ClinicalTrials.gov Identifier: NCT02402426
Recruitment Status : Recruiting
First Posted : March 30, 2015
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date August 1, 2013
First Posted Date March 30, 2015
Last Update Posted Date July 23, 2019
Study Start Date September 2013
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 27, 2015)
Alzheimer's Disease [ Time Frame: 10 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02402426 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 27, 2015)
Neurodegenerative Diseases [ Time Frame: 10 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Brain Health Registry
Official Title Brain Health Registry
Brief Summary The overall goal of this project is to identify, assess and longitudinally monitor subjects who are interested in participating in brain research. Participants will enroll through the website, BrainHealthRegistry.org, and provide informed consent prior to any study activities. The website will collect a variety of information, including participants' overall health, memory complaints, family history of dementia and Alzheimer's disease (AD), mood status, sleep, diet, and exercise—all through self-reported online questionnaires. Participants will also be ask to take online cognitive tests, and to return to the website at regular intervals, to complete follow-up questionnaires and neuropsychological assessments. Everyone over the age of 18 is welcome to participate. To join the Brain Health Registry, please visit www.BrainHealthRegistry.org.
Detailed Description

Through advertisement and community outreach, potential participants will be directed to the website, BrainHealthRegistry.org. The overall goal of this project is to identify, assess and longitudinally monitor subjects who are interested in participating in brain research. Participants will enroll through the website, BrainHealthRegistry.org, and provide informed consent prior to any study activities.

The website will include:

  1. Information about the Brain Health Registry (who is eligible to participate, the goals of the project and other relevant information about investigators and sponsors involved in the Initiative)
  2. Frequently Asked Questions (FAQs) such as "How will my information be used?", "How will patient information be safeguarded?", "What information will be requested?", "How much time will be required for registration and testing?" will be addressed for participants.
  3. General information about Alzheimer's disease and other neurodegenerative diseases discussed in lay terms Links to sites that may be of interest to participants
  4. Login to our secure Registry website

The Registry will be a large, online database of volunteers who are interested in participating in neuroscience research. While anyone over the age of 18 is welcome to join the Registry, the intent is to concentrate all efforts on enrolling participants age 55 years and older. It will consist of online tools and databases, which are HIPAA-compliant and secure.

  1. Participants will access the Registry by going to the BHR website, BrainHealthRegistry.org
  2. Participants will provide their email address and create an account and username with the Registry
  3. The Registry will send an automatic email to the participant to verify their email address
  4. Participants will read the online Information Sheet and will be asked to provide their consent by clicking either "I consent" or "I decline." Participants who decline to participate in the Registry will be automatically directed out of the Registry website
  5. Participants who give their consent will be permitted to continue through the registration process, which includes completing a battery of questionnaires designed to obtain a general understanding of participants health, medical history wellbeing
  6. In addition to questionnaires, participants will be able to complete online cognitive assessments.
  7. Participants will given the option to elect a Caregiver and/or Study Partner (CASP) to enrich their study profile.
  8. Participants may be referred to other research studies and/or clinical trials
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The Registry is a large, online database of volunteers who would like to participate in clinical trials and research. Anyone over the age of 18 is welcome to join the Registry, and the intent is to concentrate all efforts on enrolling participants age 55 years and older.
Condition
  • Healthy
  • Neurodegenerative Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 2, 2018)
100000
Original Estimated Enrollment
 (submitted: March 27, 2015)
50000
Estimated Study Completion Date September 2028
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Anyone over the age of 18 is welcome to join the Registry

Exclusion Criteria:

  • N/A
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Jacqueline Hayes info@brainhealthregistry.org
Contact: Diana Truran-Sacrey Diana.Truran@ucsf.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02402426
Other Study ID Numbers 12-09628
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of California, San Francisco
Study Sponsor University of California, San Francisco
Collaborators Not Provided
Investigators
Principal Investigator: Michael Weiner, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date July 2019