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NMDA-enhancing Agent for the Treatment of Mild Cognitive Impairment

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02239003
Enrollment
24
Registered
2014-09-12
Start date
2012-01-31
Completion date
2017-12-31
Last updated
2018-01-24

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

Conditions

Mild Cognitive Impairment

Brief summary

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

Interventions

DRUGDAOIB
DRUGPlacebo

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Clinical diagnosis of mild cognitive impairment * MMSE between 17-26 * CDR 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

Design outcomes

Primary

MeasureTime frame
Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24week 0, 8, 16, 24

Secondary

MeasureTime frame
Change from baseline in speed of processing (Category Fluency) at week 24week 0, 24
Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input at week 8, 16 and 24week 8, 16, 24
Change from baseline in working memory (Wechsler Memory Scale, Spatial Span) at week 24week 0, 24
Change from baseline in verbal learning and memory tests (Wechsler Memory Scale, Word Listing) at week 24week 0, 24

Countries

Taiwan

Outcome results

None listed

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