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NCT Number: NCT03752463

NMDA Enhancer for the Treatment of Mild Alzheimer's Disease

NMDA neurotransmission plays an important role in learning and memory. NMDA receptors (NMDAR) were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease (AD). This study is a randomized, double-blind, placebo controlled drug trial for testing the efficacy of NMDAR-enhancer. All subjects will be allocated randomly to 4 groups: (1) DAOI-A group; (2) DAOI-B group; (3) DAOI-C group; (4) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOI may yield better efficacy than placebo for cognitive function in patients with AD.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

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
  • MMSE between 10-26
  • CDR 1

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

DAOI-A group

Drug

DAOI with A dose

DAOI-B group

Drug

DAOI with B dose

DAOI-C group

Drug

DAOI with C dose

Placebo oral capsule

Drug

Placebo

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

    Cognitive assessment

Secondary outcomes

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

    Time frame: week 8, 16, 24

    Global assessment

  2. Change from baseline in speed of processing (Category Fluency) at week 24

    Time frame: week 0, 24

    Cognitive assessment

  3. Change from baseline in working memory (Wechsler Memory Scale, Spatial Span) at week 24

    Time frame: week 0, 24

    Cognitive assessment

  4. Change from baseline in verbal learning and memory tests (Wechsler Memory Scale, Word Listing) at week 24

    Time frame: week 0, 24

    Cognitive assessment

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • Ministry of Science and Technology, Taiwan

Registry information

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Nov 26, 2018
Registry last updated
Aug 26, 2021

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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