Mild Cognitive Impairment
Conditions
Brief summary
NMDA neurotransmission plays an important role in learning and memory. NMDA receptor-enhancing agent improved the cognitive function of patients with early-phase Alzheimer's disease. This study is a randomized, double-blind, placebo-controlled drug trial. All subjects will be allocated randomly to 2 groups: (1) DAOIB group; (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
oral, for 24 weeks
DRUGPlacebo
oral, for 24 weeks
Sponsors
Chang Gung Memorial Hospital
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
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 psychiatric disorders * Major physical illnesses * Severe visual or hearing impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24 | week 0, 8, 16, 24 | Alzheimer's disease assessment scale-cognitive subscale consists of 11 tasks. Its scores range from 0 (best) to 70 (worst). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the composite score of a battery of additional cognitive tests at week 8, 16 and 24 | week 0, 24 | The battery of additional cognitive tests include speed of processing (Category Fluency), working memory (verbal and nonverbal, Wechsler Memory Scale), learning and memory tests (verbal and visual, Wechsler Memory Scale) |
| Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24 | week 8, 16, 24 | Clinician's Interview-Based Impression of Change plus Caregiver Input score is a global assessment of change based on a comprehensive, semi-structured interview which includes caregiver-supplied information. It is a 7-point rating scale ranging from 1-7, where 1 represents markedly improved; 4, no change; and 7, markedly worse. |
| Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 8, 16 and 24 | week 0, 8, 16, 24 | ADCS-MCI-ADL appears to be a suitable instrument for evaluating activities of daily living in mild cognitive impairment. Its scores range from 0 (worst) to 78 (best). |
| Change from baseline in Medical Outcomes Study Short-Form-36 (SF-36) score at week 8, 16 and 24 | week 0, 8, 16, 24 | The SF-36 consists of eight sections which assess the quality of life. |
Countries
Taiwan
Outcome results
None listed