Menu
Recruiting NCT06467539

Novel Augmentation of DAOIB and Antioxidant for Early Dementia

Phase II Interventional Alzheimer Disease Mild Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DAOIB plus AO, DAOIB plus placebo.
Who it may be relevant to
Registry conditions: Alzheimer Disease, Mild Cognitive Impairment. Basic parameters: 50 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug DAOIB plus AO
    oral, for 24 weeks
  • Drug DAOIB plus placebo
    oral, for 24 weeks

Primary outcome measures

  • Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24 [Time frame: week 0, 8, 16, 24]
Secondary outcome measures (6)
  • Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24 [Time frame: week 8, 16, 24]
  • Change from baseline in Mini-Mental Status examination score at week 8, 16 and 24 [Time frame: week 0, 8, 16, 24]
  • Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score at week 8, 16 and 24 [Time frame: week 0, 8, 16, 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 [Time frame: week 0, 8, 16, 24]
  • Change from baseline in Medical Outcomes Study Short-Form-36 (SF-36) score at week 8, 16 and 24 [Time frame: week 0, 8, 16, 24]
  • Change from baseline in the composite score of a battery of additional cognitive tests at week 8, 16 and 24 [Time frame: week 0, 24]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Chang Gung Memorial Hospital — Kaohsiung City

Identifiers

NCT: NCT06467539 · 202200458A3C502

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗