Evaluating the effects of DAOIB on dementia symptoms
Efficacy Biomarkers of DAOIB for Dementia
PHASE2 · Chang Gung Memorial Hospital · NCT05582161
This study is testing if a new treatment called DAOIB can help improve symptoms in people with mild Alzheimer's disease or mild cognitive impairment over six months.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 123 (estimated) |
| Ages | 50 Years to 90 Years |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital (other) |
| Locations | 2 sites (Kaohsiung City and 1 other locations) |
| Trial ID | NCT05582161 on ClinicalTrials.gov |
What this trial studies
This open-label clinical trial aims to assess the efficacy of DAOIB in patients diagnosed with amnestic mild cognitive impairment (aMCI) or mild Alzheimer's disease (AD) over a 24-week period. Participants will undergo evaluations at baseline, 8 weeks, 16 weeks, and at the end of the study, with blood samples taken every 8 weeks to measure NMDA and oxidative stress-related biomarkers. The study hypothesizes that these biomarkers can predict the treatment's effectiveness in this patient population.
Who should consider this trial
Good fit: Ideal candidates include individuals with a clinical diagnosis of Alzheimer's disease or mild cognitive impairment, with an MMSE score between 10-26 and a CDR score of 1 or 0.5.
Not a fit: Patients with severe cognitive impairment, major depressive disorder, or other significant physical illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option for patients with aMCI or mild AD, potentially improving their cognitive function.
How similar studies have performed: While the specific approach of using DAOIB in this context may be novel, similar studies targeting biomarkers in dementia have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical diagnosis of Alzheimer's disease or mild cognitive impairment * MMSE between 10-26 * CDR 1 or 0.5 Exclusion Criteria: * Hachinski Ischemic Score \> 4 * Substance abuse/dependence * Parkinson disease, epilepsy, dementia with psychotic features * Major depressive disorder * Major physical illnesses * Severe visual or hearing impairment
Where this trial is running
Kaohsiung City and 1 other locations
- Chang Gung Memorial Hospital — Kaohsiung City, Taiwan (RECRUITING)
- China Medical University Hospital — Taichung, Taiwan (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dementia