NCT05582161 Efficacy Biomarkers of DAOIB for Dementia
| NCT ID | NCT05582161 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Chang Gung Memorial Hospital |
| Condition | Dementia |
| Study Type | INTERVENTIONAL |
| Enrollment | 123 participants |
| Start Date | 2022-10-03 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 123 participants in total. It began in 2022-10-03 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This open-label clinical trial will enroll patients with aMCI or mild AD, and they will be treated with DAOIB for 24 weeks. We will assess the patients before entering the study, 8 weeks, 16 weeks, and end point (24 weeks) of the study, and measure blood NMDA and oxidative stress - related biomarkers every 8 weeks. We hypothesize that NMDA and oxidative stress - related biomarkers can predict the efficacy of DAOIB for patients with aMCI or mild AD.
Eligibility 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
Frequently Asked Questions
Who can join the NCT05582161 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 90 Years, studying Dementia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05582161 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05582161 currently recruiting?
Yes, NCT05582161 is actively recruiting participants. Visit ClinicalTrials.gov or contact Chang Gung Memorial Hospital to inquire about joining.
Where is the NCT05582161 trial being conducted?
This trial is being conducted at Kaohsiung City, Taiwan, Taichung, Taiwan.
Who is sponsoring the NCT05582161 clinical trial?
NCT05582161 is sponsored by Chang Gung Memorial Hospital. The trial plans to enroll 123 participants.