Dementia of Alzheimer TypeNCT04680013
Genetic Studies in Familial Dementia
An observational study of Dementia of Alzheimer Type and Alzheimer Disease, Late Onset, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to identify genetic factors that contribute to or cause dementia (loss of memory) and related disorders across all ages and ethnic groups. This includes a number of neurological diseases such as early and late-onset Alzheimer disease, mild cognitive impairment, and other dementias. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia of Alzheimer Type, Alzheimer Disease, Late Onset, Alzheimer Disease, Early Onset
- How many people
- 4,884 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2007to 29 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of older individuals affected by dementia, mild cognitive impairment, cognitive controls, or their family members. Ascertainment is across both males and females, and all race-ethnic groups.
Who may be able to join
- 18 years and older
- Patients diagnosed with dementia, their family members and unrelated healthy controls without dementia.
Who cannot join
- 1. Individuals with competing diagnosis such as: Amyotrophic lateral sclerosis, Frontotemporal lobar degeneration, Multiple system atrophy, Corticobasal degeneration, Progressive Supranuclear Palsy, 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.
About this study
The purpose of this study is to identify genetic factors that contribute to or cause dementia (loss of memory) and related disorders across all ages and ethnic groups. This includes a number of neurological diseases such as early and late-onset Alzheimer disease, mild cognitive impairment, and other dementias.
- Conditions
- Dementia of Alzheimer Type, Alzheimer Disease, Late Onset, Alzheimer Disease, Early Onset, Mild Cognitive Impairment, Dementia
- Keywords
- Memory loss
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Control | Participants in this group are cognitively intact. | |
| Mild Cognitive Impairment | Participants in this group have mild cognitive impairment. | |
| Dementia Group | Participants in this group have dementia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between genetic factors and Alzheimer disease, dementia, and related phenotypes.
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: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start1 Jun 2007
- Primary completion29 Oct 2024
- Study completion29 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia of Alzheimer TypeStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Enrolment
- 4,884 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University, Columbia University, Wake Forest University, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Margaret Pericak-Vance, University of Miami
- Investigators
- Margaret Pericak-Vance, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680013
- Sponsor's protocol ID
- 20070307
- Other IDs
- RF1AG054080, RF1AG054074, U01AG052410
- Status last verified
- Feb 2025
- First submitted
- 17 Dec 2020
- Last updated
- 3 Mar 2025
- 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 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Studies in Familial Dementia
- ClinicalTrials.gov ID
- NCT04680013
- Acronym / sponsor ID
- 20070307
- Conditions
- Dementia of Alzheimer Type, Alzheimer Disease, Late Onset, Alzheimer Disease, Early Onset, Mild Cognitive Impairment, Dementia
- Keywords
- Memory loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,884 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Case Western Reserve University, Columbia University, Wake Forest University, National Institute on Aging (NIA)
- Study start
- 1 Jun 2007 (actual)
- Primary completion
- 29 Oct 2024 (actual)
- Study completion
- 29 Oct 2024 (actual)
- First posted
- 22 Dec 2020 (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 purpose of this study is to identify genetic factors that contribute to or cause dementia (loss of memory) and related disorders across all ages and ethnic groups. This includes a number of neurological diseases such as early and late-onset Alzheimer disease, mild cognitive impairment, and other dementias.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Control | – | –Participants in this group are cognitively intact. |
| Mild Cognitive Impairment | – | –Participants in this group have mild cognitive impairment. |
| Dementia Group | – | –Participants in this group have dementia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of older individuals affected by dementia, mild cognitive impairment, cognitive controls, or their family members. Ascertainment is across both males and females, and all race-ethnic groups.
Key inclusion criteria (2 listed)
- 18 years and older
- Patients diagnosed with dementia, their family members and unrelated healthy controls without dementia.
Key exclusion criteria (1 listed)
- 1. Individuals with competing diagnosis such as: Amyotrophic lateral sclerosis, Frontotemporal lobar degeneration, Multiple system atrophy, Corticobasal degeneration, Progressive Supranuclear Palsy, 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.
Primary outcome
Correlation between genetic factors and Alzheimer disease, dementia, and related phenotypes.
Time frame: 5 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. .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- NIA Genomics of Alzheimer Disease Storage siteLink provided by the sponsor.
- 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 of Alzheimer Type
RecruitingPhase 2
A Study to Investigate the Safety and Effectiveness of SAR448851 in Participants With Early Alzheimer's Disease
Dementia, Alzheimer's Type, Alzheimer's Disease
RecruitingObservational study
Neurofilament Light Chain And Voice Acoustic Analyses In Dementia Diagnosis
Neurodegenerative Diseases, Dementia
Active, not recruitingPhase 3
Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type
Agitation, Alzheimer's Type Dementia
RecruitingPhase 1/2
Large-coil Parietal Repetitive Transcranial Magnetic Stimulation (rTMS) for Alzheimer Disease (AD)
Alzheimer&Amp;Amp;#39;s Disease, Alzheimer Disease
Recruiting
Autonomic Involvement in Patient With Cognitive Decline
Dementia, Mild, Dementia of Alzheimer Type
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. This study is not recruiting at the moment.
Margaret Pericak-Vance, PhD principal investigator
University of Miami
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 of Alzheimer Type and Alzheimer Disease, Late Onset, run by University of Miami 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: finished, as of the sponsor's last update on 3 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between genetic factors and Alzheimer disease, dementia, and related phenotypes. (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 3 Mar 2025; AzTrials last refreshed its copy on 3 Nov 2026.