- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04680013
Genetic Studies in Familial Dementia
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Michael Prough
- Phone Number: 877-686-6444
- Email: AD-HIHG@miami.edu
Study Locations
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Florida
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Miami, Florida, United States, 33136
- Recruiting
- University of Miami
-
Contact:
- Michael Prough
- Phone Number: 877-686-6444
- Email: AD-HIHG@miami.edu
-
Principal Investigator:
- Margaret Pericak-Vance, PhD
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Principal Investigator:
- Gary Beecham, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years and older
- Patients diagnosed with dementia, their family members and unrelated healthy controls without dementia.
Exclusion Criteria:
1. Individuals with competing diagnosis such as: Amyotrophic lateral sclerosis, Frontotemporal lobar degeneration, Multiple system atrophy, Corticobasal degeneration, Progressive Supranuclear Palsy, Huntington's disease, traumatic brain injury, drug or alcohol abuse, or schizophrenia, etc. (unless family members of a dementia affected individual).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Cognitive Control
Participants in this group are cognitively intact.
|
Mild Cognitive Impairment
Participants in this group have mild cognitive impairment.
|
Dementia Group
Participants in this group have dementia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between genetic factors and Alzheimer disease, dementia, and related phenotypes.
Time Frame: 5 years
|
Genetic factors will be measured through genome-wide genotyping arrays and/or whole-genome sequencing, and then correlated with Alzheimer disease and related phenotypes, such as cognitive impairment, functional impairment, and relevant biomarkers. . |
5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Margaret Pericak-Vance, PhD, University of Miami
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20070307
- RF1AG054080 (U.S. NIH Grant/Contract)
- RF1AG054074 (U.S. NIH Grant/Contract)
- U01AG052410 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Data from this study will be shared via government required repositories and with our collaborators. Data are coded, with no personally identifiable information included. Data shared include the genomic data (array data, sequence data, APOE genotyping results, etc), phenotype data (case/control status, age of onset, etc), and basic demographic information (sex, race/ethnicity data if available, etc).
The NIH Genomic Data Sharing Policy (GDS Policy) took effect on January 25th, 2015. This necessitates that we send coded data and samples to the National Institute on Aging Genetics of Alzheimer's Disease (NIAGADS)l; in some cases materials derived from participants (blood or DNA) may be stored at the National Cell Repository for Alzheimer's Disease (NCRAD).
We may share deidentified genomic and phenotypic data with collaborators at other sites in order the accomplish the scientific aims of the study. Such research is performed with the approval of the local internal review boards.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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