Genetic Studies of Early-onset Dementia
3 other identifiers
observational
1,000
1 country
1
Brief Summary
The aim of this study is to identify genetic factors that contribute to risk and progression of early-onset dementia (loss of memory function before the age of 70 years) across all ethnic groups, including Alzheimer's Disease, mild cognitive impairment and other dementias.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 14, 2016
CompletedFirst Submitted
Initial submission to the registry
May 25, 2021
CompletedFirst Posted
Study publicly available on registry
May 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2028
April 29, 2026
April 1, 2026
11.6 years
May 25, 2021
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Genetic risk variants associated with early-onset dementia
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.
2 years
Changes in blood biomarkers in early-onset dementia
Blood biomarkers including plasma amyloid beta and tau protein will be assessed in blood and correlated with onset and progression of memory loss and functional impairment
2 years
Study Arms (4)
Mild Cognitive Impairment
Individuals with mild cognitive impairment that began before age 70
Dementia/Alzheimer's Disease
Individuals with Alzheimer's Disease or other dementia that began before age 70
Cognitively Healthy
Cognitively healthy individuals over the age of 35 years with a family history of dementia.
Early-onset dementia prior to the age of 65.
Individuals diagnosed with early-onset dementia prior to the age of 65.
Interventions
Blood draw for identification of genetic variants associated with the development of memory problems
Brief memory test
Collection of medical history
Eligibility Criteria
The study population consists of individuals affected by dementia, mild cognitive impairment, cognitively healthy individuals with a family history of dementia. Ascertainment is across both males and females, and all race-ethnic groups.
You may qualify if:
- years and older
- Individuals experiencing memory concerns or diagnosed with dementia and their family members that are unrelated healthy controls without dementia.
You may not qualify if:
- \- Individuals with competing diagnosis such as Huntington's disease, traumatic brain injury, drug or alcohol abuse, or schizophrenia, etc., unless family members of a dementia affected individual
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- University of Miamicollaborator
- National Institute on Aging (NIA)collaborator
Study Sites (1)
Columbia University Irving Medical Center
New York, New York, 10032, United States
Biospecimen
Approximately 40ml of blood and/or saliva
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christiane Reitz, MD, PhD
Columbia University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Neurology and Epidemiology
Study Record Dates
First Submitted
May 25, 2021
First Posted
May 28, 2021
Study Start
September 14, 2016
Primary Completion (Estimated)
April 30, 2028
Study Completion (Estimated)
April 30, 2028
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- This study adheres to the NIA Alzheimer Disease Genomics Data Sharing Plan (https://www.nia.nih.gov/research/dn/alzheimers-disease-genomics-sharing-plan). As such, genomic data will be deposited in NIH/NIA data repositories (www.niagads.org). For genomic data, this typically happens within a year of data generation, or upon publication in scientific journals (whichever is sooner). Basic phenotypic data (affection status, age of onset, sex, family structure if applicable, etc) are deposited with the genomic data. More detailed phenotypic data (cognitive data, biomarker, etc) will be made available upon publication. Data dictionaries for primary data (genomic data and basic phenotypic data) will be available with the deposition of data into the NIH/NIA data repositories (www.niagads.org). Additional supporting documentation (analysis plans, study protocols, etc) is typically described in detail upon publication of results in peer reviewed literature.
- Access Criteria
- This study adheres to the NIA Alzheimer disease Genomics Data Sharing Plan (https://www.nia.nih.gov/research/dn/alzheimers-disease-genomics-sharing-plan). As part of this plan data distribution agreements are required before recipients receive any data from this study. The primary requirements for the DDA include language ensuring that (1) data are not transferred to others beyond the initial recipient, (2) no attempt will be made to identify participants, (3) any results or data generated as part of the study will be shared back to NIA/NIAGADS. See the NIA Data Distribution Agreement (https://www.niagads.org/sites/all/public\ files/NIAGADS-DDA.pdf) and Alzheimer's Disease Genomics Sharing Plan (https://www.nia.nih.gov/research/dn/alzheimers-disease-genomics-sharing-plan) for more details.
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.