DAOIB Combined With tDCS for Early-phase Dementia

Phase 2

Completed

• Conditions: Transcranial Direct Current Stimulation; Dementia
• Interventions: Drug: Placebo; Drug: DAOIB; Device: tDCS

• Registration Number: NCT04737096
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

This is a 24-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 2 treatment groups for 24 weeks: (1) DAOIB group; (2) placebo group. We will assess the patients every 8 weeks during the treatment period (weeks 0, 8, 16, and 24). We hypothesize that augmentation with 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2021-01-27
• Study First Submitted QC: 2021-01-31
• Study First Posted: 2021-02-03
• Status Verified: 2023-01
• Primary Completion: 2023-01-02
• Study Completion: 2023-01-02
• Last Update Submitted: 2023-01-04
• Last Update Posted: 2023-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tDCS+placebo	Placebo	-
tDCS+DAOIB	DAOIB	-
tDCS+DAOIB	tDCS	-
tDCS+placebo	tDCS	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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
Change from baseline in Quality of life score at week 8, 16 and 24	week 0, 8, 16, 24	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.
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)

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan