Novel Augmentation of DAOIB and Antioxidant for Early Dementia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-90
SponsorChang Gung Memorial Hospital
About this trial
Previous studies found that some NMDA-enhancing agents were able to improve cognitive function of patients with early-phase dementia. In addition, several drugs with antioxidant properties have been tested in clinical trials for the treatment of dementia too. Whether combined treatment of an NMDA-enhancing agent and a drug with antioxidant property can be better than an NMDA-enhancing agent alone deserves study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of Alzheimer's disease or mild cognitive impairment
MMSE between 10-26
CDR 1 or 0.5
Disqualifiers
Hachinski Ischemic Score > 4
Substance abuse/dependence
Parkinson disease, epilepsy, dementia with psychotic features
Major depressive disorder
Trial design
Design model
Parallel
Treatments tested in this trial
DAOIB plus AO
Drugoral, for 24 weeks
DAOIB plus placebo
Drugoral, for 24 weeks
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: ExperimentalExperimental treatment 1 intervention
Group B: Placebo ComparatorPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24
Alzheimer's disease assessment scale-cognitive subscale consists of 11 tasks. Its scores range from 0 (best) to 70 (worst).
Time frame
week 0, 8, 16, 24Secondary outcomes
1
Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 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.
Time frame
week 8, 16, 242
Change from baseline in Mini-Mental Status examination score at week 8, 16 and 24
Change from baseline in Mini-Mental Status examination score at week 8, 16 and 24
Time frame
week 0, 8, 16, 243
Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score at week 8, 16 and 24
Clinical Dementia Rating Scale (CDR) is a global assessment tool that yields global and Sum of Boxes scores (SB). Compared to the global CDR score, the CDR-SB score provides better utility in tracking changes in dementia severity.
Time frame
week 0, 8, 16, 244
Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 8, 16 and 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).
Time frame
week 0, 8, 16, 24Sponsors and contacts
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Source ClinicalTrials.gov