Dementia
Conditions
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.
Interventions
DRUGDAOIB
The DAOIB dose will be adjusted every 8 weeks according to clinical evaluation.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
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
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 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 24 | week 0, 24 | The battery of additional cognitive tests include speed of processing (Category Fluency), working memory (Wechsler Memory Scale, Spatial Span), verbal/nonverbal learning and memory tests (Wechsler Memory Scale, Word Listing) |
| 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 | Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24 |
| 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 | The assessment appears to be a suitable instrument for evaluating activities of daily living in early-phase dementia. Its scores range from 0 (worst) to 78 (best) |
| Change from baseline of Geriatric Depression Scale | week 0, 8, 16, 24 | Assessment of geriatric depressive symptoms |
| Change from baseline in Mini-Mental Status examination score at week 8, 16 and 24 | week 0, 8, 16, 24 | Change from baseline in Mini-Mental Status examination score at week 8, 16 and 24 |
Countries
Taiwan
Outcome results
None listed