δ in Dementia Clinical Trials

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO · Oct 19, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how to improve methods for assessing dementia and cognitive decline, specifically in patients with Alzheimer's Disease and mild cognitive impairment. Researchers want to see if they can better evaluate the effects of a medication called donepezil by looking at a combination of cognitive performance and daily functioning, which they refer to as a "latent variable" (δ). They will also examine whether certain biological markers in the blood can help identify which patients are most likely to benefit from the treatment. Participants will be recruited from those who have recently been prescribed donepezil and will be grouped based on their predicted response to the medication.

To be eligible for the trial, participants should be between 65 and 100 years old, have a clinical diagnosis of Alzheimer's Disease or mild cognitive impairment, and be able to give informed consent. They must also have a caregiver who can provide regular support and information about their cognitive status. Participants can expect to be interviewed by phone and monitored throughout the study to evaluate any changes in their dementia severity. It's important to note that certain medical conditions or treatments can disqualify someone from participating, so potential participants should discuss their specific situation with their doctor.

Gender

ALL

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) ≤ 6.
• • 6. No significant visual or hearing impairments
• • 7. A standardized dECog score between 1.5 and 3.5 relative to ADNI's cohort.
• • 8. Assignment to "Group 1" by a LOI assessment of Adipokine adjusted v. unadjusted dECog scores.
• • 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. 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.
• 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 or treatment for atrial fibrillation;
• • 4. History of bradycardia or syncopal events;
• • 5. Chronic diarrhea, h/o colonic resection or irritable bowel syndrome;
• • 6. Treatment for cancer in the last 5 years (excluding skin cancers);
• • 7. Major surgery in the last year;
• • 8. Treatment for a seizure disorder with anticonvulsants
• • 9. Current treatment with donepezil or any other AChEI or exposure within the last year.
• • 10. Treatment with opiates, muscle relaxants, or systemic steroids.
• • 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. 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. Co-participation in another study that the PI feels would pose a safety risk or adversely affect data integrity of this study.