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DC Longitudinal Study on Aging and Specimen Bank
NCT03702907 · Georgetown University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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.
Eligibility criteria
Inclusion Criteria:
* Age 45 and older.
* Subjects within the age range of 45-50 years old must have a first degree relative with a neurodegenerative disease.
Exclusion Criteria:
* Individuals under 45 years of age
Study design
Enrollment target: 1000 participants
Age groups: adult, older_adult
Timeline
Starts: 2007-01-01
Estimated completion: 2027-01
Last updated: 2019-10-24
Primary outcomes
- • CDR (9 years)
Sponsor
Georgetown University · other
All locations (1)
Georgetown University Memory Disorders ProgramRecruiting
Washington D.C., District of Columbia, United States