Dementia, Early OnsetNCT04906863
Genetic Studies of Early-onset Dementia
An observational study of Dementia, Early Onset and Alzheimer Dementia (AD), run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Early Onset, Alzheimer Dementia (AD), Mild Cognitive Impairment (MCI)
- What is being tested?
- Blood draw, Neurocognitive testing and Medical questionnaire
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2016to 30 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 35 years and older
- Individuals experiencing memory concerns or diagnosed with dementia and their family members that are unrelated healthy controls without dementia.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Pamela del Rosario, MD, 212-304-7284, pd2727@cumc.columbia.edu
Christiane Reitz, MD PhD
About this study
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.
Read the 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.
- Conditions
- Dementia, Early Onset, Alzheimer Dementia (AD), Mild Cognitive Impairment (MCI), Memory Loss
- Being tested
- Blood draw, Neurocognitive testing, Medical questionnaire
- Keywords
- Alzheimer's Disease, Memory loss, Early-onset Alzheimer's disease, Mild cognitive impairment, Normal cognition, Dementia, Genetics
- Medical subject headings
- Dementia, Alzheimer Disease, Cognitive Dysfunction, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawGenetic
Blood draw for identification of genetic variants associated with the development of memory problems
Neurocognitive testingOther
Brief memory test
Medical questionnaireOther
Collection of medical history
| Study group | Role | What they receive |
|---|---|---|
| Mild Cognitive Impairment | Individuals with mild cognitive impairment that began before age 70 Receives: Genetic: Blood draw; Other: Neurocognitive testing; Other: Medical questionnaire | |
| Dementia/Alzheimer's Disease | Individuals with Alzheimer's Disease or other dementia that began before age 70 Receives: Genetic: Blood draw; Other: Neurocognitive testing; Other: Medical questionnaire | |
| Cognitively Healthy | Cognitively healthy individuals over the age of 35 years with a family history of dementia. Receives: Genetic: Blood draw; Other: Neurocognitive testing; Other: Medical questionnaire | |
| Early-onset dementia prior to the age of 65. | Individuals diagnosed with early-onset dementia prior to the age of 65. Receives: Genetic: Blood draw; Other: Neurocognitive testing; Other: Medical questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start14 Sep 2016
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia, Early OnsetStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Christiane Reitz, MD, PhD, Columbia University
- Investigators
- Christiane Reitz, MD, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906863
- Sponsor's protocol ID
- AAAQ9793
- Other IDs
- 5U24AG056270-07, 1R01AG064614
- Status last verified
- Apr 2026
- First submitted
- 25 May 2021
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Studies of Early-onset Dementia
- ClinicalTrials.gov ID
- NCT04906863
- Acronym / sponsor ID
- AAAQ9793
- Conditions
- Dementia, Early Onset, Alzheimer Dementia (AD), Mild Cognitive Impairment (MCI), Memory Loss
- Keywords
- Alzheimer's Disease, Memory loss, Early-onset Alzheimer's disease, Mild cognitive impairment, Normal cognition, Dementia, Genetics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- University of Miami, National Institute on Aging (NIA)
- Study start
- 14 Sep 2016 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mild Cognitive Impairment | – | Genetic: Blood draw, Other: Neurocognitive testing, Other: Medical questionnaireIndividuals with mild cognitive impairment that began before age 70 |
| Dementia/Alzheimer's Disease | – | Genetic: Blood draw, Other: Neurocognitive testing, Other: Medical questionnaireIndividuals with Alzheimer's Disease or other dementia that began before age 70 |
| Cognitively Healthy | – | Genetic: Blood draw, Other: Neurocognitive testing, Other: Medical questionnaireCognitively healthy individuals over the age of 35 years with a family history of dementia. |
| Early-onset dementia prior to the age of 65. | – | Genetic: Blood draw, Other: Neurocognitive testing, Other: Medical questionnaireIndividuals diagnosed with early-onset dementia prior to the age of 65. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 35 years and older
- Individuals experiencing memory concerns or diagnosed with dementia and their family members that are unrelated healthy controls without dementia.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawBlood draw for identification of genetic variants associated with the development of memory problems | Genetic | Cognitively Healthy, Dementia/Alzheimer's Disease, Early-onset dementia prior to the age of 65., Mild Cognitive Impairment |
| Neurocognitive testingBrief memory test | Other | Cognitively Healthy, Dementia/Alzheimer's Disease, Early-onset dementia prior to the age of 65., Mild Cognitive Impairment |
| Medical questionnaireCollection of medical history | Other | Cognitively Healthy, Dementia/Alzheimer's Disease, Early-onset dementia prior to the age of 65., Mild Cognitive Impairment |
Primary outcome
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: 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.
Related trials for Dementia, Early Onset
Active, not recruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease
Alzheimer Disease, Early Onset
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 1
A Study to Evaluate the Safety and Tolerability of ALN-APP in Patients With EOAD
Early-Onset Alzheimer Disease
Active, not recruitingPhase 1
Study of Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of NIO752 in Early Alzheimer's Disease Participants
Alzheimer Disease, Mild Cognitive Impairment
RecruitingPhase 1/2
Study of ARO-MAPT-SC in Healthy Participants and Participants With Early Alzheimer's Disease
Alzheimer Disease, Alzheimer Disease, Early Onset
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christiane Reitz, MD, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, Early Onset and Alzheimer Dementia (AD), run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pamela Del Rosario (212-304-7284, pd2727@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic risk variants associated with early-onset dementia (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.