DAOIBplusAO is a novel combination therapy being investigated in this Phase 2 trial at Chang Gung Memorial Hospital in Kaohsiung City, Taiwan. The trial evaluates whether combined treatment with an NMDA-enhancing agent (DAOIB) and an antioxidant (AO) provides better cognitive outcomes than DAOIB alone in patients with early-phase dementia[1].
Previous studies have found that NMDA-enhancing agents can improve cognitive function in patients with early-phase dementia[2]. Additionally, several drugs with antioxidant properties have been tested in clinical trials for dementia treatment[3]. This trial tests the hypothesis that combined treatment may be superior to monotherapy.
| Attribute | Details |
|---|---|
| NCT Number | NCT06467539 |
| Sponsor | Chang Gung Memorial Hospital |
| Drug | DAOIB plus Antioxidant (AO) |
| Phase | Phase 2 |
| Indication | Alzheimer's Disease, Mild Cognitive Impairment |
| Status | Recruiting |
| Participants | 80 |
| Study Start | 2024-06-19 |
| Estimated Completion | 2027-05 |
| Location | Kaohsiung City, Taiwan |
| Duration | 24 weeks |
The NMDA (N-methyl-D-aspartate) receptor is a glutamate receptor subtype critical for synaptic plasticity and memory formation. In Alzheimer's disease:
NMDA-enhancing agents modulate NMDA receptor activity to improve synaptic signaling and potentially preserve cognitive function.
Oxidative stress plays a key role in Alzheimer's disease pathogenesis:
Antioxidant compounds may:
The combination approach addresses multiple pathogenic pathways simultaneously:
| Component | Target | Purpose |
|---|---|---|
| DAOIB | NMDA receptors | Enhance synaptic signaling |
| AO | Oxidative stress | Reduce ROS damage |
This dual mechanism may provide additive or synergistic benefits compared to either approach alone.
| Arm | Type | Intervention |
|---|---|---|
| Experimental | Drug | DAOIB plus Antioxidant agent (AO) |
| Comparator | Placebo | DAOIB plus Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| ADAS-Cog Change | Alzheimer's Disease Assessment Scale - Cognitive subscale change from baseline | Week 0, 8, 16, 24 |
The ADAS-Cog consists of 11 tasks assessing cognitive function, with scores ranging from 0 (best) to 70 (worst).
| Measure | Description | Time Frame |
|---|---|---|
| CIBIC+ | Clinician's Interview-Based Impression of Change plus Caregiver Input | Week 8, 16, 24 |
| MMSE | Mini-Mental Status Examination score change | Week 8, 16, 24 |
| CDR-SB | Clinical Dementia Rating Scale Sum of Boxes | Week 8, 16, 24 |
| ADCS-MCI-ADL | Alzheimer's Disease Cooperative Study scale for ADL in MCI | Week 8, 16, 24 |
| SF-36 | Medical Outcomes Study Short-Form-36 (quality of life) | Week 8, 16, 24 |
| Composite Cognitive Tests | Battery including speed of processing, working memory, learning and memory | Week 0, 24 |
This trial targets early-phase dementia for several reasons:
Monotherapy approaches have shown limited efficacy in AD: