RECRUITING

δ in Dementia Clinical Trials

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Novel Methods for Clinical Trials in Dementia and Cognitive Decline

Quick Facts

Study Start:2024-08-05
Study Completion:2028-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05592678

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Ambulatory outpatient volunteers with competent informants. Competent informants are cognitively normal individual(s) who interacts with the person on a regular (at least 5 or more hours/week) basis and in the opinion of the PI can provide adequate collateral information on the participant's memory and cognitive status.
  2. 2. Aged 65-100 years
  3. 3. Clinical diagnosis of AD, or MCI.
  4. 4. Capacity to give informed consent. If a patient is found to clinically decline during the course of the study and no longer able to provide consent, continued participation will be evaluated by the PI on a case-by-case basis.
  5. 5. GDS score (15 item) ≤ 6.
  6. 6. No significant visual or hearing impairments
  7. 7. A standardized dECog score between 1.5 and 3.5 relative to ADNI's cohort.
  8. 8. Assignment to "Group 1" by a LOI assessment of Adipokine adjusted v. unadjusted dECog scores.
  9. 9. In the opinion of the participant's physician, Donepezil is medically indicated for the treatment of memory impairment and the participant has obtained a prescription for it. .
  10. 10. Physician instructions are in line with a titration to a dosage of 10 mg Qd per the standard dosing guidelines for Donepezil. If participant not able to tolerate 5 mg titration over 4 weeks, PI will need to authorize continued enrollment.
  1. 1. A history of psychosis, including visual hallucinations;
  2. 2. History or treatment for Parkinson's, or tremor, or Rapid Eye Movement (REM) behavior disorder;
  3. 3. History or treatment for atrial fibrillation;
  4. 4. History of bradycardia or syncopal events;
  5. 5. Chronic diarrhea, h/o colonic resection or irritable bowel syndrome;
  6. 6. Treatment for cancer in the last 5 years (excluding skin cancers);
  7. 7. Major surgery in the last year;
  8. 8. Treatment for a seizure disorder with anticonvulsants
  9. 9. Current treatment with donepezil or any other AChEI or exposure within the last year.
  10. 10. Treatment with opiates, muscle relaxants, or systemic steroids.
  11. 11. In the opinion of the PI, treatment with AChEI is not appropriate due to a possible negative risk/benefit ratio based on past medical history or endorsement of symptoms during the screening interview.
  12. 12. In the opinion of the treating physician, the patient must begin therapy with AChEI immediately due to any delays having an unacceptable impact on the patient's QoL.
  13. 13. Co-participation in another study that the PI feels would pose a safety risk or adversely affect data integrity of this study.

Contacts and Locations

Study Contact

Samuel Guess
CONTACT
210 567 8133
guesss@uthscsa.edu
Floyd Jones
CONTACT
210 450 3158
JONESFA@uthscsa.edu

Principal Investigator

Donald R. Royall, MD
PRINCIPAL_INVESTIGATOR
University of Texas

Study Locations (Sites)

Univeristy of Texas Health Science Center at San Antonio (UTHSCSA)
San Antonio, Texas, 78229-3900
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center at San Antonio

  • Donald R. Royall, MD, PRINCIPAL_INVESTIGATOR, University of Texas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-05
Study Completion Date2028-11

Study Record Updates

Study Start Date2024-08-05
Study Completion Date2028-11

Terms related to this study

Keywords Provided by Researchers

  • adipokines
  • cognition
  • dementia
  • functional status
  • intelligence

Additional Relevant MeSH Terms

  • Alzheimer's Disease (AD)
  • Dementia
  • Cognitive Decline
  • Mild Cognitivie Impairment (MCI)