Alzheimer DiseaseLOADNCT05010603
Late Onset Alzheimer's Disease
An observational study of Alzheimer Disease, run by Columbia University at 12 sites in United States.
Trial summary
The goal of this study is to is to focus on the genetic influences on Alzheimer's Disease (AD) risk. The investigators are looking for families and/or individuals (affected or unaffected) of any ethic background (African American, Caucasian, and Hispanics) with a family history of AD and willing to participate. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Blood Draw and Late Onset Alzheimer's Disease (LOAD) Neuropsychological Battery Test
- How many people
- 10,000 participants
- Where
- 12 sitesUnited States
- Study dates
- 15 Nov 2016to 30 Apr 2027
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The investigators intend to recruit individuals from: 1) community-based studies; 2) the Alzheimer's Disease Research Center Memory Disorders Center; 3) the private offices of the study neurologists; 4) public recruitment; 5) referrals from the Alzheimer's Association; 6) referrals from the NCRAD; 7)previously unidentified members of existing families not previously recruited. The investigators will also use advertisements such as radio, television and newspapers.
Who may be able to join
- Established diagnosis of definite or probable AD or have a diagnosis of a related neurodegenerative disorder such as Frontotemporal Dementia (FTD) or Lewy Body Dementia (LBD) (will also recruit sporadic FTD and LBD) cases.
- a living sibling with probable or possible AD;
- a third living relative affected with AD (onset age 50 or older) or unaffected (60 or older);
- participants in the proband's generation with an identified companion serving as an informant;
- participants who have capacity to consent or participants lacking capacity to consent with a surrogate/proxy in place to provide consent.
Who cannot join
- failure to identify an appropriate informant;
- uncertainty of the clinical diagnosis of Alzheimer's disease or other related disorder;
- discovery of additional diagnosis that could account for the clinical manifestations;
- unwillingness to participate;
- failure to identify a living sibling with AD or other related disorder (except in the cases of sporadic FTD and sporadic LBD);
- participants lacking the capacity to consent who do not have a surrogate or proxy or next of kin to provide consent.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
Rush University
Aurora, Illinois, 60612
Corey Woods
- Recruiting
Indiana University
Bloomington, Indiana, 47405
Kelly Farber
- Recruiting
University of Texas Southwestern
Dallas, Texas, 75390
Amy Browning
- Recruiting
NCRAD at Indiana University
Indianapolis, Indiana, 46202
Kelly Farber
- Recruiting
University of Miami
Miami, Florida, 33124
Larry Deon
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Dolly Reyes-Dumeyer, 212-305-5953, dr2290@cumc.columbia.edu
Amanda Chan, 917-696-3082, akc2177@cumc.columbia.edu
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Elise Weamer
- Recruiting
North Carolina State University
Raleigh, North Carolina, 27695
Takiyah Starks
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55901
Christine Hanzel
- Recruiting
University of Washington
Seattle, Washington, 98195
- Recruiting
Joanne Norton
St Louis, Missouri, 63130
Joanne Norton
- Recruiting
University of Washington
Washington D.C., District of Columbia, 98105
Sarah Payne
About this study
The goal of this study is to is to focus on the genetic influences on Alzheimer's Disease (AD) risk. The investigators are looking for families and/or individuals (affected or unaffected) of any ethic background (African American, Caucasian, and Hispanics) with a family history of AD and willing to participate.
Read the detailed description
The purpose of this study is to focus on the genetic influences on Alzheimer's disease (AD) risk. Specifically, the investigators hypothesize that one or more genes, other than the previously identified susceptibility gene apolipoprotein-E (APOE), or the 3 genes associated with early-onset familial AD, presenilin-1 (PS-1), presenilin-2 (PS-2) or B-amyloid precursor protein (APP), increase the risk of AD in families with multiple individuals affected with AD. The investigators propose to test this hypothesis by performing genetic linkage analysis in order to detect the chromosomal location of genes that may increase the risk of Alzheimer's disease. In addition, the investigators will study genes known to increase the risk of Alzheimer's disease and other related disorders such as early onset AD, Pick disease, corticobasal degeneration, progressive supranuclear palsy, and familial frontotemporal dementia with parkinsonism and Lewy Body Dementia.
- Conditions
- Alzheimer Disease
- Being tested
- Blood Draw, Late Onset Alzheimer's Disease (LOAD) Neuropsychological Battery Test
- Keywords
- Genetic testing, Genetic influence
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawGenetic
Collection of blood samples for genetic testing
Late Onset Alzheimer's Disease (LOAD) Neuropsychological Battery TestOther
Memory Test
| Study group | Role | What they receive |
|---|---|---|
| Families with a history of Alzheimer's Disease | Families with two or more family members affected with Alzheimer's Disease Receives: Genetic: Blood Draw; Other: Late Onset Alzheimer's Disease (LOAD) Neuropsychological Battery Test | |
| Un-related, non-demented controls | Un-related, non-demented healthy controls over age 55 Receives: Genetic: Blood Draw; Other: Late Onset Alzheimer's Disease (LOAD) Neuropsychological Battery Test | |
| Individuals with Dementia (Alzheimer's Disease) | Individuals with dementia over the age of 65 Receives: Genetic: Blood Draw; Other: Late Onset Alzheimer's Disease (LOAD) Neuropsychological Battery Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of genes identified to be associated with the risk of AD
Genetic Linkage Analysis to Identify Genes Associated with the risk of Alzheimer's Disease: Identification of genes by performing genetic linkage analysis, in order to detect the chromosomal location of genes that may increase the risk of Alzheimer's disease.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start15 Nov 2016
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Richard P. Mayeux, MD, MSc, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010603
- Sponsor's protocol ID
- AAAP0479
- Other IDs
- 5U24AG056270
- Acronym
- LOAD
- Status last verified
- May 2026
- First submitted
- 11 Aug 2021
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data is stored in a secured database at Columbia University and de-identified data will be sent to the National Cell Repository for Alzheimer's disease. DNA will be stored at the National Cell Repository for Alzheimer's disease (NCRAD) at Indiana University. In addition to the blood sample, year of birth, family history of dementia, and diagnosis will be sent to NCRAD. DNA and associated clinical and demographic data will be made available to qualified and approved researchers studying the genetics of AD, aging, and related disorders. If the participant agrees, his/her de-identified samples and data will be made available to investigators studying the genetics of any human disease. Identity of participants will not be shared with NCRAD or with any investigators.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late Onset Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05010603
- Acronym / sponsor ID
- LOAD / AAAP0479
- Conditions
- Alzheimer Disease
- Keywords
- Genetic testing, Genetic influence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 18 Aug 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 goal of this study is to is to focus on the genetic influences on Alzheimer's Disease (AD) risk. The investigators are looking for families and/or individuals (affected or unaffected) of any ethic background (African American, Caucasian, and Hispanics) with a family history of AD and willing to participate.
Detailed description
The purpose of this study is to focus on the genetic influences on Alzheimer's disease (AD) risk. Specifically, the investigators hypothesize that one or more genes, other than the previously identified susceptibility gene apolipoprotein-E (APOE), or the 3 genes associated with early-onset familial AD, presenilin-1 (PS-1), presenilin-2 (PS-2) or B-amyloid precursor protein (APP), increase the risk of AD in families with multiple individuals affected with AD. The investigators propose to test this hypothesis by performing genetic linkage analysis in order to detect the chromosomal location of genes that may increase the risk of Alzheimer's disease. In addition, the investigators will study genes known to increase the risk of Alzheimer's disease and other related disorders such as early onset AD, Pick disease, corticobasal degeneration, progressive supranuclear palsy, and familial frontotemporal dementia with parkinsonism and Lewy Body Dementia.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Families with a history of Alzheimer's Disease | – | Genetic: Blood Draw, Other: Late Onset Alzheimer's Disease (LOAD) Neuropsychological Battery TestFamilies with two or more family members affected with Alzheimer's Disease |
| Un-related, non-demented controls | – | Genetic: Blood Draw, Other: Late Onset Alzheimer's Disease (LOAD) Neuropsychological Battery TestUn-related, non-demented healthy controls over age 55 |
| Individuals with Dementia (Alzheimer's Disease) | – | Genetic: Blood Draw, Other: Late Onset Alzheimer's Disease (LOAD) Neuropsychological Battery TestIndividuals with dementia over the age of 65 |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators intend to recruit individuals from: 1) community-based studies; 2) the Alzheimer's Disease Research Center Memory Disorders Center; 3) the private offices of the study neurologists; 4) public recruitment; 5) referrals from the Alzheimer's Association; 6) referrals from the NCRAD; 7)previously unidentified members of existing families not previously recruited. The investigators will also use advertisements such as radio, television and newspapers.
Key inclusion criteria (5 listed)
- Established diagnosis of definite or probable AD or have a diagnosis of a related neurodegenerative disorder such as Frontotemporal Dementia (FTD) or Lewy Body Dementia (LBD) (will also recruit sporadic FTD and LBD) cases.
- a living sibling with probable or possible AD;
- a third living relative affected with AD (onset age 50 or older) or unaffected (60 or older);
- participants in the proband's generation with an identified companion serving as an informant;
- participants who have capacity to consent or participants lacking capacity to consent with a surrogate/proxy in place to provide consent.
Key exclusion criteria (6 listed)
- failure to identify an appropriate informant;
- uncertainty of the clinical diagnosis of Alzheimer's disease or other related disorder;
- discovery of additional diagnosis that could account for the clinical manifestations;
- unwillingness to participate;
- failure to identify a living sibling with AD or other related disorder (except in the cases of sporadic FTD and sporadic LBD);
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 DrawCollection of blood samples for genetic testing | Genetic | Families with a history of Alzheimer's Disease, Individuals with Dementia (Alzheimer's Disease), Un-related, non-demented controls |
| Late Onset Alzheimer's Disease (LOAD) Neuropsychological Battery TestMemory Test | Other | Families with a history of Alzheimer's Disease, Individuals with Dementia (Alzheimer's Disease), Un-related, non-demented controls |
Primary outcome
Total number of genes identified to be associated with the risk of AD
Time frame: 5 years
Genetic Linkage Analysis to Identify Genes Associated with the risk of Alzheimer's Disease: Identification of genes by performing genetic linkage analysis, in order to detect the chromosomal location of genes that may increase the risk of Alzheimer's disease.
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 18 May 2026.
- Individual participant dataSharing planned: Yes. Data is stored in a secured database at Columbia University and de-identified data will be sent to the National Cell Repository for Alzheimer's disease. DNA will be stored at the National Cell Repository for Alzheimer's disease (NCRAD) at Indiana University. In addition to the blood sample, year of birth, family history of dementia, and diagnosis will be sent to NCRAD. DNA and associated clinical and demographic data will be made available to qualified and approved researchers studying the genetics of AD, aging, and related disorders. If the participant agrees, his/her de-identified samples and data will be made available to investigators studying the genetics of any human disease. Identity of participants will not be shared with NCRAD or with any investigators.
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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.
Richard P. Mayeux, MD, MSc principal investigator
Columbia University
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Columbia University at 12 sites 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 5 inclusion and 6 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 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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 Dolly Reyes-Dumeyer (212-305-5953, dr2290@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of genes identified to be associated with the risk of AD (time frame: 5 years). 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 18 May 2026.