Genetic Studies of Early-onset Dementia

April 24, 2026 updated by: Christiane Reitz, MD, PhD, Columbia University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study population includes individuals with Alzheimer's disease, mild cognitive impairment, other forms of dementia, as well as cognitively healthy individuals with a family history of dementia. Participants include males and females across all racial and ethnic groups.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
        • Principal Investigator:
          • Christiane Reitz, MD PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion criteria:

  • 35 years and older
  • Individuals experiencing memory concerns or diagnosed with dementia and their family members that are unrelated healthy controls without dementia.

Exclusion Criteria:

- 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mild Cognitive Impairment
Individuals with mild cognitive impairment that began before age 70
Genetic: Blood draw
Blood draw for identification of genetic variants associated with the development of memory problems
Other: Neurocognitive testing
Brief memory test
Other: Medical questionnaire
Collection of medical history
Dementia/Alzheimer's Disease
Individuals with Alzheimer's Disease or other dementia that began before age 70
Genetic: Blood draw
Blood draw for identification of genetic variants associated with the development of memory problems
Other: Neurocognitive testing
Brief memory test
Other: Medical questionnaire
Collection of medical history
Cognitively Healthy
Cognitively healthy individuals over the age of 35 years with a family history of dementia.
Genetic: Blood draw
Blood draw for identification of genetic variants associated with the development of memory problems
Other: Neurocognitive testing
Brief memory test
Other: Medical questionnaire
Collection of medical history
Early-onset dementia prior to the age of 65.
Individuals diagnosed with early-onset dementia prior to the age of 65.
Genetic: Blood draw
Blood draw for identification of genetic variants associated with the development of memory problems
Other: Neurocognitive testing
Brief memory test
Other: Medical questionnaire
Collection of medical history

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genetic risk variants associated with early-onset dementia
Time Frame: 2 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.
2 years
Changes in blood biomarkers in early-onset dementia
Time Frame: 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

University of Miami
National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Christiane Reitz, MD, PhD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2016

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

May 25, 2021

First Submitted That Met QC Criteria

May 25, 2021

First Posted (Actual)

May 28, 2021

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAQ9793
  • 5U24AG056270-07 (U.S. NIH Grant/Contract)
  • 1R01AG064614 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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

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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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