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Completed

NCT Number: NCT04736355

DAOIB for the Treatment of Mild Cognitive Impairment

NMDA neurotransmission plays an important role in learning and memory. NMDA receptor-enhancing agent improved the cognitive function of patients with early-phase Alzheimer's disease. This study is a randomized, double-blind, placebo-controlled drug trial. All subjects will be allocated randomly to 2 groups: (1) DAOIB group; (2) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOIB may yield better efficacy than placebo for cognitive function in patients with mild cognitive impairment.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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 mild cognitive impairment
  • MMSE between 17-26
  • CDR 0.5

Exclusion criteria

  • Hachinski Ischemic Score > 4
  • Substance abuse/dependence
  • Parkinson disease, epilepsy, dementia with psychotic features
  • Major psychiatric disorders
  • Major physical illnesses
  • Severe visual or hearing impairment

Treatment and study plan

DAOIB

Drug

oral, for 24 weeks

Placebo

Drug

oral, for 24 weeks

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 consists of 11 tasks. Its 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

    Clinician's Interview-Based Impression of Change plus Caregiver Input score is a global assessment of change based on a comprehensive, semi-structured interview which includes caregiver-supplied information. It is a 7-point rating scale ranging from 1-7, where 1 represents markedly improved; 4, no change; and 7, markedly worse.

  2. 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

    ADCS-MCI-ADL appears to be a suitable instrument for evaluating activities of daily living in mild cognitive impairment. Its scores range from 0 (worst) to 78 (best).

  3. Change from baseline in Medical Outcomes Study Short-Form-36 (SF-36) score at week 8, 16 and 24

    Time frame: week 0, 8, 16, 24

    The SF-36 consists of eight sections which assess the quality of life.

  4. Change from baseline in the composite score of a battery of additional cognitive tests at week 8, 16 and 24

    Time frame: week 0, 24

    The battery of additional cognitive tests include speed of processing (Category Fluency), working memory (verbal and nonverbal, Wechsler Memory Scale), learning and memory tests (verbal and visual, Wechsler Memory Scale)

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Feb 3, 2021
Registry last updated
Aug 21, 2024

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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