NMDA-enhancing Agent for Treatment of Mild Cognitive Impairment and Mild Alzheimer's Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01600469

Enrollment

Registered

2012-05-17

Start date

2012-01-31

Completion date

2013-05-31

Last updated

2013-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease, Mild Cognitive Impairment

Keywords

Alzheimer's disease, mild cognitive impairment, NMDA

Brief summary

NMDA activation plays an important role in learning and memory. NMDA receptors were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease and mild cognitive function impairment. This study is a randomized, double-blind, placebo-controlled drug trial. All patients will be allocated randomly to 2 groups: (1) NMDA enhancer: DAOI-B group (starting dose: 250-500 mg/d); (2) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOI-B may yield better efficacy than placebo for cognitive function in patients with mild cognitive impairment or mild Alzheimer's disease.

Interventions

DRUGDAOI-B

250-1500 mg/day, oral, for 24 weeks

OTHERPlacebo

placebo, oral, for 24 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Clinical diagnosis of mild cognitive impairment or mild Alzheimer's * MMSE between 17-26 * CDR 0.5 or 1

Exclusion criteria

* Hachinski Ischemic Score \> 4 * substance abuse/dependence * Parkinson disease * epilepsy * major depressive disorder * dementia with psychotic features * major physical illnesses * severe visual or hearing impairment

Design outcomes

Primary

Measure	Time frame
Change from baseline in Alzheimer's disease assessment scale-cognitive subscale in week 8, 16 and 24	Week 0, 8, 16, 24

Secondary

Measure	Time frame
Change from baseline in Mini Mental Status Examination at week 8, 16 and 24	Week 0, 8, 16, 24
Change from baseline in Instrumental Activities of Daily Living at week 8, 16 and 24	Week 0, 8, 16, 24
Change from baseline in Verbal learning and memory at week 24	Week 0, 24
Change from baseline in Digit Span subtest of the Wechsler Memory Scale at week 24	Week 0, 24

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026