An observational study in Dementia, Early Onset, Alzheimer Dementia (AD) and Mild Cognitive Impairment (MCI), sponsored by Columbia University. Recruiting at 1 site in United States. Open to participants aged 35 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Columbia University · Observational
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.
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.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 200 across 814 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
Compared within Alzheimer Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dementia. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Individuals with mild cognitive impairment that began before age 70
Genetic: Blood draw · Other: Neurocognitive testing · Other: Medical questionnaire
Individuals with Alzheimer's Disease or other dementia that began before age 70
Genetic: Blood draw · Other: Neurocognitive testing · Other: Medical questionnaire
Cognitively healthy individuals over the age of 35 years with a family history of dementia.
Genetic: Blood draw · Other: Neurocognitive testing · Other: Medical questionnaire
Individuals diagnosed with early-onset dementia prior to the age of 65.
Genetic: Blood draw · Other: Neurocognitive testing · Other: Medical questionnaire
Blood draw for identification of genetic variants associated with the development of memory problems
Brief memory test
Collection of medical history
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.
Time frame: 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
Time frame: 2 years
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, 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.
No publications or documents are linked to this record.
Started Sep 2016 (actual). Primary completion is estimated for Apr 2028, 139 months after the start.
Of 364 non-industry observational studies under Alzheimer Disease, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 203. This study's planned 139 months is above that.
Counting every sponsor, half of 405 studies reached it within 67 months; a quarter within 35 and three quarters within 171.
How these figures are worked out, and which studies are left out of them.
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