DAOIB Combined With tDCS for Early-phase Dementia

• Sponsor: Chang Gung Memorial Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04737096
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 30.9
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Transcranial Direct Current Stimulation; Dementia	Drug: DAOIB; Drug: Placebo; Device: tDCS	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: DAOIB Combined With tDCS for Early-phase Dementia - a Randomized, Double-blinded and Placebo Controlled Clinical Trial
• Actual Study Start Date: Jan 1, 2020
• Anticipated Primary Completion Date: Jul 30, 2022
• Anticipated Study Completion Date: Jul 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: tDCS+DAOIB	Drug: DAOIB; The DAOIB dose will be adjusted every 8 weeks according to clinical evaluation.; Device: tDCS; tDCS
Placebo Comparator: tDCS+placebo	Drug: Placebo; placebo; Device: tDCS; tDCS

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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)

4. 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.

5. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung		Taiwan	886

Sponsors and Collaborators

• Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chang Gung Memorial Hospital
• ClinicalTrials.gov Identifier: NCT04737096
• Other Study ID Numbers: 201601789A0C603
• First Posted: Feb 3, 2021
• Last Update Posted: Mar 10, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dementia

Study Results

No Results Posted as of Mar 10, 2022