The Dose Finding Study of DAOIB Added to tDCS for AD

Chang Gung Medical Foundation

Status and phase: Suspended; Phase 2

Conditions: Transcranial Direct Current Stimulation; Dementia

Treatments: Drug: DAOIB

Study type: Interventional

Funder types: Other

Identifiers

NCT05006781

202002208A0

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 50 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 4 patient groups, including a placebo group

tDCS+Dose A

Experimental group

Description:

Drug: DAOIB at dose A The DAOIB dose will be fixed during the 24 weeks duration. Device: tDCS tDCS

Treatment:

Drug: DAOIB

tDCS+Dose B

Experimental group

Description:

Drug: DAOIB at dose B The DAOIB dose will be fixed during the 24 weeks duration. Device: tDCS tDCS

Treatment:

Drug: DAOIB

tDCS+Dose C

Experimental group

Description:

Drug: DAOIB at dose C The DAOIB dose will be fixed during the 24 weeks duration. Device: tDCS tDCS

Treatment:

Drug: DAOIB

tDCS+placebo

Placebo Comparator group

Description:

Drug: Placebo Placebo Device: tDCS tDCS

Treatment:

Drug: DAOIB