Novel Augmentation of DAOIB and Antioxidant for Early Dementia

Alzheimer Disease Clinical Trial

Official title:

Novel Augmentation of DAOIB and Antioxidant for Early Dementia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06467539
• Other study ID #: 202200458A3C502
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: May 2027

Study information

• Verified date: June 2024
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: May 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	week 0, 8, 16, 24
Secondary	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.	week 8, 16, 24
Secondary	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	week 0, 8, 16, 24
Secondary	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.	week 0, 8, 16, 24
Secondary	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).	week 0, 8, 16, 24
Secondary	Change from baseline in Medical Outcomes Study Short-Form-36 (SF-36) score at week 8, 16 and 24	The SF-36 consists of eight sections which assess the quality of life.	week 0, 8, 16, 24
Secondary	Change from baseline in the composite score of a battery of additional cognitive tests at week 8, 16 and 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).	week 0, 24