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Dementia / Alzheimer's

δ in Dementia Clinical Trials

Recruiting · San Antonio, Texas

Always free

Study care at no cost to you

For your time and travel

Many studies pay you back

Most need no insurance or papers

Legal status usually isn't required; we'll tell you each study's requirements

Interpreters available

Ask for your language

Your choice

Voluntary — you can stop anytime

What is this study?

The goal of this clinical trial is to demonstrate potential improvements in clinical trial methods relating to dementia and cognitive decline. The main questions it aims to answer are: * Can an intervention's outcome be better assessed by a latent variable ("δ") integrating cognitive performance with functional status?

It is , overseen by an independent and licensed medical staff.

Read the full clinical description

The goal of this clinical trial is to demonstrate potential improvements in clinical trial methods relating to dementia and cognitive decline. The main questions it aims to answer are: * Can an intervention's outcome be better assessed by a latent variable ("δ") integrating cognitive performance with functional status? * Can latent biomarkers of δ guide the selection of an intervention that will modulate dementia severity? * Can a latent variable, derived from information collected remotely from caregivers, preselect subjects most likely to respond to the intervention? * Is the effect of the intervention in fact medicated by changes in the targeted biomarker? In this case, the biomarker will be a latent variable derived from several proteins measured in blood (i.e., so-called "adipokines"). The intervention will be donepezil, a medication approved for the treatment of Alzheimer's Disease, but only recently associated with adipokine changes. Participants with cognitive impairment and their caregivers will be interviewed by telephone and those newly prescribed donepezil by their provider for cognitive impairment will be recruited and enrolled. On the basis of the caregiver's report, the cognitively impaired subjects will be assigned to two groups based on a prediction of their response to donepezil. Researchers will compare those groups to see if dementia severity, as measured by δ, improves in predicted responders, and whether the change in the d-score is mediated by changes in adipokines.

Are you a good fit?

Simplified highlights. The study team always confirms the full details with you.

  • Adults roughly 65–100
  • !Some conditions may not be a fit: Anxiety

What to expect, step by step

  1. 1

    Usually a few weeks

    The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.

  2. 2

    Treatment

    If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.

  3. 3

    Follow-up

    After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.

Has this treatment been tested before?

The study team can share what safety testing has been done so far.

What you need to know before you apply

What is this study testing?+

The goal of this clinical trial is to demonstrate potential improvements in clinical trial methods relating to dementia and cognitive decline. The main questions it aims to answer are: * Can an intervention's outcome be better assessed by a latent variable ("δ") integrating cognitive performance with functional status?

Is it safe? Who makes sure of that?+

This is a research study. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.

Will I get a placebo instead of the real treatment?+

Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.

Do I have to stop taking my current medications?+

It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.

Does it cost anything? Will I be paid?+

Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.

Do I need insurance? Will anyone ask about my immigration status?+

No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.

What if English isn't my first language?+

You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.

Is my information private?+

Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.

Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.

Source: ClinicalTrials.gov · NCT05592678 · Locations: Texas