Improving dementia treatment assessment methods

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to enhance the evaluation of interventions for dementia and cognitive decline by utilizing a latent variable, referred to as 'δ', which integrates cognitive performance with functional status. The study will involve pre-selecting participants based on their likelihood to benefit from the medication donepezil, which is approved for Alzheimer's Disease, and assessing its effects on dementia severity. Additionally, the trial will explore the role of adipokines as potential biomarkers that could mediate the treatment's effectiveness. Participants will be monitored through remote assessments conducted by caregivers to identify those most likely to respond to the intervention.

Why it matters

Who can join: the full rules

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.

Where it's running

• Univeristy of Texas Health Science Center at San Antonio (UTHSCSA)
  San Antonio, Texas, United States Recruiting

Study contacts

• Principal investigator: Donald R. Royall, MD — University of Texas
• Study coordinator: Samuel Guess
• Email: guesss@uthscsa.edu
• Phone: 210 567 8133

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• China HEAD: a large community study on healthy aging and dementia

  This study tests whether collecting health, imaging, and biospecimen data from adults in China can help predict who will develop Alzheimer’s disease and related dementias.

  Recruiting at 30 sites Fudan University · Beijing and 29 other locations · NCT07912710

• Feasibility of a Smartphone App to Support Mental Well-Being for Older Adults and Caregivers

  This pilot test checks whether the utmbHealthyBrain app can be used in community settings by adults 50+ and their caregivers to support mood and social connection over six weeks.

  Recruiting The University of Texas Medical Branch, Galveston · Galveston, Texas · NCT07313540

• Lifestyle intervention for older adults at risk of dementia

  This study is testing a personalized lifestyle program to see if it can help older adults at risk of dementia improve their brain health over a year.

  Recruiting Maastricht University Medical Center · Amsterdam and 1 other locations · NCT06832761

• Using brain stimulation and digital training to improve cognitive function in older adults

  This study is testing whether a combination of brain stimulation and digital training can help improve thinking skills in older adults with Mild Cognitive Impairment and Alzheimer's Disease.

  Recruiting Universidade Federal do Rio de Janeiro · Rio de Janeiro, Rio de Janeiro · NCT06733714

• Effects of different anesthesia techniques on cognitive function in elderly hip fracture patients

  This study tests different anesthesia methods to see which one helps older patients with hip fractures keep their thinking skills sharp during and after surgery.

  Recruiting at 8 sites Second Affiliated Hospital of Wenzhou Medical University · Dongyang, Zhejiang and 12 other locations · NCT06452147

• Combining sleep promotion and cognitive training to improve brain function in older ICU survivors

  This study is testing if helping older adults who survived ICU treatment sleep better and do brain exercises can improve their thinking skills.

  Recruiting University of Washington · Seattle, Washington · NCT06411561

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.