Tennessee Alzheimer's Project
Tennessee Alzheimer's Project: Studying Brain Health in Aging Adults
Plain English Summary
Tennessee Alzheimer's Project is a Not Applicable clinical trial sponsored by Vanderbilt University Medical Center studying Aging, Alzheimer Disease, Biomarker, Cognitive Dysfunction, Mild Cognitive Impairment, Dementia, Cognition. This study observes individuals to better understand aging and Alzheimer's disease. It is for adults aged 60 and older who have normal cognition, mild cognitive impairment, or Alzheimer's disease. Participants will have annual check-ups including cognitive tests and brain imaging. There is no direct treatment tested; it supports research for future treatments. The trial aims to enroll 1000 participants.
Official Summary
The primary objective of the Vanderbilt Alzheimer's Disease Research Center (VADRC) is to provide local and national researchers with access to a well-characterized and diverse clinical cohort, including participant referrals, biosamples, clinical data, and neuroimaging data. The VADRC Clinical Core will create an infrastructure to support research efforts of both local and national investigator studies to develop early detection, prevention, and treatment strategies for Alzheimer's disease. The Clinical Core intends to enroll up to 1000 participants, including individuals who are cognitively unimpaired, have mild cognitive impairment, or have Alzheimer's disease. This cohort of about 1000 participants will be called the Tennessee Alzheimer's Project. Participants will be seen annually for comprehensive clinical characterization and then referred to other studies to enhance Alzheimer's disease research activities.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 60 or older and have normal thinking, mild memory problems, or Alzheimer's disease. You must be able to speak English and make your own decisions about participating. You cannot join if you don't have someone who can help with study information and visits. Certain brain conditions, severe mental health issues, or inability to have an MRI will prevent participation. This trial is studying Aging, Alzheimer Disease, Biomarker, Cognitive Dysfunction, Mild Cognitive Impairment, Dementia, Cognition, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
Cognitive status and brain imaging will be tracked over time to see how thinking abilities and brain structure change, helping researchers understand the progression of Alzheimer's. The specific primary outcome measures are: Cognitive status (baseline to year 3); APOE Genotype (baseline to year 3); White matter hyperintensities Volume (baseline to year three); Grey Matter Volume (baseline to year three); Cerebral Blood Flow (baseline to year three). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is crucial for building a diverse group of participants to accelerate the development of new ways to detect, prevent, and treat Alzheimer's disease. This research targets Aging, Alzheimer Disease, Biomarker, Cognitive Dysfunction, Mild Cognitive Impairment, Dementia, Cognition, where improved treatment options are needed.
Investor Insight
This observational study by Vanderbilt University Medical Center aims to create a valuable research resource, potentially attracting further funding and partnerships for Alzheimer's research. The large enrollment target of 1000 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor about how this study relates to your current health and if it's a good fit. Participation involves annual visits for cognitive assessments, medical history updates, and possibly brain scans. Your information and samples will help researchers understand Alzheimer's better. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 1,000 participants
Interventions
- OTHER: none, observational study — none, observational study
Primary Outcomes
- Cognitive status (baseline to year 3)
- APOE Genotype (baseline to year 3)
- White matter hyperintensities Volume (baseline to year three)
- Grey Matter Volume (baseline to year three)
- Cerebral Blood Flow (baseline to year three)
Full Eligibility Criteria
Inclusion Criteria: * Age 60 or older * Meet standard criteria for (a) cognitively unimpaired, (b) mild cognitive impairment, or (c) Alzheimer's disease * English speaking * Individuals who lack decisional capacity to provide informed consent at baseline will not be enrolled in the study Exclusion Criteria: * No available reliable study partner (reliable is defined as someone who interacts significantly with the participant and is available to participate in study visits in person or by phone) * History of major psychiatric illness (e.g., schizophrenia, bipolar), neurological illness (e.g., epilepsy, multiple sclerosis, Parkinson's disease), or head injury with significant loss of consciousness. * Unable to undergo MRI (e.g., claustrophobia, ferrous metal in body)
Trial Locations
- Vanderbilt University Medical Center, Nashville, Tennessee, United States
Frequently Asked Questions
What is clinical trial NCT05372172?
NCT05372172 is a Not Applicable OBSERVATIONAL study titled "Tennessee Alzheimer's Project." It is currently recruiting and is sponsored by Vanderbilt University Medical Center. The trial targets enrollment of 1000 participants.
What conditions does NCT05372172 study?
This trial investigates treatments for Aging, Alzheimer Disease, Biomarker, Cognitive Dysfunction, Mild Cognitive Impairment, Dementia, Cognition. The primary condition under study is Aging.
What treatments are being tested in NCT05372172?
The interventions being studied include: none, observational study (OTHER). none, observational study
What does Not Applicable mean for NCT05372172?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT05372172?
This trial is currently "Recruiting." It started on 2021-10-27. The estimated completion date is 2030-03-31.
Who is sponsoring NCT05372172?
NCT05372172 is sponsored by Vanderbilt University Medical Center. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05372172?
The trial aims to enroll 1000 participants. The trial is currently recruiting and accepting new participants.
How is NCT05372172 designed?
This is a observational study.
What are the primary outcomes being measured in NCT05372172?
The primary outcome measures are: Cognitive status (baseline to year 3); APOE Genotype (baseline to year 3); White matter hyperintensities Volume (baseline to year three); Grey Matter Volume (baseline to year three); Cerebral Blood Flow (baseline to year three). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05372172 being conducted?
This trial is being conducted at 1 site, including Nashville, Tennessee (United States).
Where can I find official information about NCT05372172?
The official record for NCT05372172 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05372172. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05372172 testing in simple terms?
This study observes individuals to better understand aging and Alzheimer's disease. It is for adults aged 60 and older who have normal cognition, mild cognitive impairment, or Alzheimer's disease.
Why is this trial significant?
This trial is crucial for building a diverse group of participants to accelerate the development of new ways to detect, prevent, and treat Alzheimer's disease.
What are the potential risks of participating in NCT05372172?
The main risk is the time commitment for annual visits. Some procedures like MRI scans have minor risks, such as discomfort or allergic reactions to contrast dye if used. There are no direct treatments given, so there are no treatment-related side effects. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05372172?
Ask your doctor about how this study relates to your current health and if it's a good fit. Participation involves annual visits for cognitive assessments, medical history updates, and possibly brain scans. Your information and samples will help researchers understand Alzheimer's better. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05372172 signal from an investment perspective?
This observational study by Vanderbilt University Medical Center aims to create a valuable research resource, potentially attracting further funding and partnerships for Alzheimer's research. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will have annual check-ups including cognitive tests and brain imaging. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.