The Dose Finding Study of DAOIB Added to tDCS for AD

Dementia Clinical Trial

Official title:

The Dose Finding Study of Sodium Benzoate Added to tDCS for the Treatment of Early-phase Alzheimer's Disease

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05006781
• Other study ID #: 202002208A0
• Status: Suspended
• Phase: Phase 2
• Start date: January 2025
• Est. completion date: December 2027

Study information

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

Clinical Trial Summary

This is a 26-week randomized, double-blind, placebo-controlled trial. We will enroll patients with aMCI or mild AD. All patients will receive 2 weeks of tDCS (5 sessions per week, 10 sessions in total) during the first 2 weeks of the study, and will also be allocated randomly to either of 4 treatment groups for 24 weeks: (1) Dose A group; (2) Dose B group; (3) Dose C group; (4) placebo group. We will assess the patients every 8 weeks during the treatment period (weeks 0, 10, 18, and 26). We hypothesize that augmentation with certain dose of DAOIB will yield better effect than tDCS alone in improving the cognitive function, global functioning and quality of life in patients with aMCI or mild AD.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 140
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 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

• Dementia
• Transcranial Direct Current Stimulation

Intervention

Drug:
• DAOIB
The DAOIB dose in each group will be fixed during the 24 weeks duration

Locations

Country	Name	City	State
Taiwan	Kaohsiung 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 10, 18 and 26	Alzheimer's disease assessment scale-cognitive subscale scores range from 0 (best) to 70 (worst)	week 0, 10, 18, 26
Secondary	Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 10, 18 and 26	Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 10, 18 and 26	week 10, 18, 26
Secondary	Change from baseline in Mini-Mental Status examination score at week 10, 18 and 26	Change from baseline in Mini-Mental Status examination score at week 10, 18 and 26	week 0, 10, 18, 26
Secondary	Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 10, 18 and 26	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)	week 0, 10, 18, 26
Secondary	Change from baseline in Quality of life score at week 10, 18 and 26	Quality of life will be assessed by Medical Outcomes Study Short-Form-36 (SF-36). The SF-36 consists of eight sections: (1) vitality, (2) physical functioning, (3) bodily pain, (4) general health perceptions, (5) physical role functioning, (6) emotional role functioning, (7) social role functioning, and (8) mental health.	week 0, 10, 18, 26
Secondary	Change from baseline in the composite score of a battery of additional cognitive tests at week 26	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).	week 0, 26