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δ in Dementia Clinical Trials

Novel Methods for Clinical Trials in Dementia and Cognitive Decline

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
65 Years to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests better ways to measure dementia and predict who may benefit from donepezil, an Alzheimer's medicine. It uses caregiver reports, tests of thinking and daily skills, and blood protein levels. It is for adults ages 65–100 with Alzheimer's disease or mild cognitive impairment who have a caregiver and are newly prescribed donepezil.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are ages 65–100.
  • Can walk, are not staying in a hospital, and have someone who can report on their health and daily skills.
  • Have a diagnosis of Alzheimer's disease or mild cognitive impairment, which means mild problems with memory or thinking.
  • Can understand the study and agree to join.
  • Score 8 or lower on the 15-question GDS depression test.
  • Have no major trouble seeing or hearing.
  • Have a standardized dECog score from 1.0 to 5.0 compared with the ADNI study group.

Who can't join

  • Have a history of psychosis, such as seeing things that are not there; or a history of or treatment for Parkinson's disease, shaking called tremor, or a sleep disorder that causes people to act out dreams.
  • Have a history of a slow heartbeat or fainting.
  • Had cancer treatment in the past 5 years, except for skin cancer, or major surgery in the past year.
  • Take medicine to prevent seizures for a seizure disorder, or antipsychotic medicine for agitation or psychosis. Treatment for anxiety or trouble sleeping is allowed.
  • Take donepezil or another medicine in the same group, called AChEIs, now or have taken one in the past 6 months.
  • Started donepezil less than 2 weeks ago and cannot stop it for 14 days before joining.
  • The study doctor and referring clinician decide that the risks of AChEI treatment outweigh its benefits based on your health history and symptoms.
  • Are in another study that the lead study doctor thinks could make this study unsafe or affect its results.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

TX