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δ in Dementia Clinical Trials

NCT05592678 · The University of Texas Health Science Center at San Antonio
In plain English

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Official title
Novel Methods for Clinical Trials in Dementia and Cognitive Decline
About this study
Title: "Novel Methods for Clinical rials in Dementia and Cognitive Decline" Study Description: This is a double-blind assignment clinical study to test novel approaches to clinical trial methods. 1) The study team will pre-select cases most likely to benefit from adipokine modulation by a telephone assessment. 2) The study team will pre-select subjects with clinical and preclinical dementia most likely to respond to therapy. 3) The study team will test the drug donepezil's effect on dementia severity, in predicted responders and non-responders, as measured by a latent dementia phenotype "δ' and 4) test a latent Adipokines biomarker construct as a mediator of their association in the predicted responders. Objectives: Primary Objective: To assess donepezil's effect on dementia severity as measured by δ in LOI subgroups and across LOI subgroups. Secondary Objective: To test Adipokines as a mediator of donepezil's effect on dTEL. Tertiary/Exploratory: To test whether donepezil reverses dementia in cases preselected to by "LOI" analysis.
Eligibility criteria
Inclusion Criteria: 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. Aged 65-100 years 3. Clinical diagnosis of AD, or MCI. 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. GDS score (15 item) ≤ 8 6. No significant visual or hearing impairments 7. A standardized dECog score between 1.5 and 3.5 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. Treatment for cancer in the last 5 years (excluding skin cancers); 4. Major surgery in the last year; 5. Treatment for a seizure disorder with anticonvulsants 6. Current treatment with donepezil or any other AChEI or exposure within the last year. 7. Treatment with opiates, muscle relaxants, or systemic steroids. 8. 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. 9. 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. 10. Co-participation in another study that the PI feels would pose a safety risk or adversely affect data integrity of this study.
Study design
Enrollment target: 200 participants
Allocation: non_randomized
Masking: quadruple
Age groups: older_adult
Timeline
Starts: 2024-08-05
Estimated completion: 2028-11-30
Last updated: 2026-04-14
Interventions
Other: Donepezil
Primary outcomes
  • dTEL change (At baseline, and weeks 4, 12 and 24.)
Sponsor
The University of Texas Health Science Center at San Antonio · other
With: National Institute on Aging (NIA)
Contacts & investigators
ContactSamuel Guess · contact · guesss@uthscsa.edu · 210 567 8133
ContactFloyd Jones · contact · JONESFA@uthscsa.edu · 210 450 3158
InvestigatorDonald R. Royall, MD · principal_investigator, University of Texas
All locations (1)
Univeristy of Texas Health Science Center at San Antonio (UTHSCSA)Recruiting
San Antonio, Texas, United States
δ in Dementia Clinical Trials · TrialPath