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Alzheimer Disease(DC LSOA)NCT03702907

DC Longitudinal Study on Aging and Specimen Bank

An observational study of Alzheimer Disease and Dementia, run by Georgetown University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The Georgetown University Memory Disorders Program, part of the Department of Neurology, is conducting pilot studies of the feasibility of various diagnostic tests for Alzheimer's disease, mild cognitive impairment and other neurodegenerative diseases. Read more about this study

Who is it for?
Ages 45 years and olderHealthy volunteers can take part
How many people
1,000 participants
Where
1 siteUnited States
Study dates
1 Jan 2007to Jan 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 45 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: All genders, races, and ethnicities eligible. Normal controls and those diagnosed with a neurodegenerative disorder eligible.

Who may be able to join

  • Age 45 and older.
  • Subjects within the age range of 45-50 years old must have a first degree relative with a neurodegenerative disease.

Who cannot join

  • Individuals under 45 years of age

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
  • Georgetown University Memory Disorders Program

    Washington D.C., District of Columbia, 20057

    Kelly McCann, 202-687-0413, keb53@georgetown.edu

    Recruiting

Other trials in United States

About this study

The Georgetown University Memory Disorders Program, part of the Department of Neurology, is conducting pilot studies of the feasibility of various diagnostic tests for Alzheimer's disease, mild cognitive impairment and other neurodegenerative diseases. Further, this study is assessing longitudinal changes in biological, lifestyle, and cognitive assessment collection.

The primary goal of this study is to examine the feasibility of biochemical assays, genetic testing, and cognitive and lifestyle assessments in the ante-mortem diagnosis of Alzheimer's disease, mild cognitive impairment and other neurodegenerative diseases. This research involves genetic and cognitive status testing but the findings will not be shared with research subjects. This will be accomplished ex vivo using blood, and/or cerebrospinal fluid (CSF) specimens from patients with a diagnosis of probable Alzheimer's disease, mild cognitive impairment, or other neurodegenerative diseases and from normal controls.

Read the detailed description

These studies will examine the feasibility of using various biochemical assays in blood, and/or cerebrospinal fluid, genetic testing, cognitive status assessments, and lifestyle questionnaires to aid in the ante-mortem diagnosis of Alzheimer's and other neurodegenerative diseases.

Subjects have 2 options for participation. They may solely participate in the main study or the main study and the longitudinal substudy. The main study includes a single visit at which demographic and medical information will be recorded, brief cognitive testing, and blood and/or cerebrospinal fluid (CSF)(optional) specimens will be collected for the research assays. Genetic testing will take place. No clinical laboratory testing will be done and no results will be communicated to subjects.

During the Longitudinal substudy, each subject will be asked to participate in ongoing longitudinal study visits at which demographic and medical information will be recorded, cognitive testing and lifestyle questionnaire collection will occur, and blood and/or cerebrospinal fluid (CSF) specimens will be collected for the research assays. I

If one is eligible and agrees to participate in the longitudinal sub-study, they will be asked to come into the clinic for an Initial Study Visit, and then return every year or every other year, depending on which group they fit into (Cognitively Normal (CN), Mild Cognitive Impairment (MCI), Alzheimer's Disease (AD), other neurodegenerative disease) for ongoing Follow-Up Clinic Visits.

CN participants will come into the clinic every other year, with telephone checks occurring on alternating years, until the study ends.

MCI, AD, and other participants with a diagnosis of any other neurodegenerative disease will come into the clinic every year until the study ends.

Those in the Cognitively Normal group, will also partake in a short Telephone Visit on the year that they do not come into the clinic. This phone call will be done only to assess/update your medical history and medications.

Genetic testing will take place. No clinical laboratory testing will be done and no results will be communicated to subjects. Those who are deemed to be cognitively normal, assessed by cognitive status instruments, will be asked to return to the clinic for ongoing study visits every other year, with telephone visits on the off year. Those who have a diagnosis of MCI, AD, or any other neurodegenerative disease will be asked to return to the clinic yearly for their longitudinal follow-up study visits.

For both the main and longitudinal sub-study, specimens will be banked for future use and can be provided to other researchers at Georgetown University, other institutions or commercial enterprise in a de-identified manner through a formal request system. For all investigators, not affiliated with the Memory Disorders Program, a formal request will be submitted to the PI for review. If the request is approved, requested specimens and/or data from the study will be sent in a de-identified manner to ensure date security and privacy. The reason for the option of data sharing is to enhance exploration of different lines of analysis, and assist emerging investigators with access to a database with robust data and specimen collections.

Keywords
Frontotemporal Dementia, Lewy Body Dementia, Aging, Vascular Dementia
Medical subject headings
Alzheimer Disease, Dementia, Cognitive Dysfunction, Frontotemporal Dementia, Lewy Body Disease, Dementia, Vascular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03702907
Study groupRoleWhat they receive
Normal CognitionNo diagnosis of a cognitive disorder
Cognitive DisorderDiagnosed with a cognitive disorder such as :Mild Cognitive Impairment, Alzheimer's disease, Frontotemporal Dementia, Lewy Body Dementia, Vascular Dementia, or other neurodegenerative condition.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CDR

    Clinical Dementia Rating

    Measured: 9 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2018
  2. Study start1 Jan 2007
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03702907
Sponsor's protocol ID
2007-249
Acronym
(DC LSOA)
Status last verified
Oct 2019
First submitted
9 Oct 2018
Last updated
24 Oct 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Alzheimer Disease and Dementia, run by Georgetown 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 24 Oct 2019. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CDR (time frame: 9 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 24 Oct 2019; AzTrials last refreshed its copy on 27 Oct 2026.

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