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Completed

NCT Number: NCT04737096

DAOIB Combined With tDCS for Early-phase Dementia

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.

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Key information

Conditions

Transcranial Direct Current Stimulation Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 886, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DAOIB

Drug

The DAOIB dose will be adjusted every 8 weeks according to clinical evaluation.

Placebo

Drug

placebo

tDCS

Device

tDCS

Primary outcomes

  1. Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24

    Time frame: week 0, 8, 16, 24

    Alzheimer's disease assessment scale-cognitive subscale scores range from 0 (best) to 70 (worst)

Secondary outcomes

  1. Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

DAOIB Combined With tDCS for Early-phase Dementia - a Randomized, Double-blinded and Placebo Controlled Clinical Trial

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 3, 2021
Registry last updated
Jan 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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