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Scientists aim to smarter design dementia trials

NCT ID NCT05592678

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests new methods to improve how dementia clinical trials are run. Researchers want to see if a combined score of thinking and daily function can better measure treatment effects. They will also check if blood proteins can predict who responds to the Alzheimer's drug donepezil. About 200 people with mild cognitive impairment or Alzheimer's, aged 65-100, and their caregivers will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Ambulatory outpatient volunteers with co-informants. 2. Aged 65-100 years 3. Clinical diagnosis of AD, or MCI. 4. Capacity to give informed consent. 5. GDS score (15 item) ≤ 8. 6. No significant visual or hearing impairments 7. Standardized dECog score between 1.0 and 5.0 relative to ADNI's cohort. Exclusion Criteria: 1. A history of psychosis, including visual hallucinations; 2. History or treatment for Parkinson's, or tremor, or Rapid Eye Movement (REM) behavior disorder; 3. History of bradycardia or syncopal events; 4. Treatment for cancer in the last 5 years (excluding skin cancers); 5. Major surgery in the last year; 6. Treatment for a seizure disorder with anticonvulsants; 7. Treatment for agitation or psychosis with neuroleptics (treatment of anxiety or insomnia allowed); 8. Current treatment with donepezil or any other AChEI or exposure within the last six months 9. With a recently started Donepezil Rx (\< 2 weeks), inability to stop Donepezil treatment for 14 days prior to study enrollment. 10. AChEI treatment not appropriate due to negative risk/benefit ratio based on medical Hx and symptoms during screening. Evaluated by PI and referring clinician. 11. Co-participation in another study that the PI feels would pose a safety risk or adversely affect data integrity of this study.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction dementia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Univeristy of Texas Health Science Center at San Antonio (UTHSCSA)

    RECRUITING

    San Antonio, Texas, 78229-3900, United States

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