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NCT Number: NCT02239003

NMDA-enhancing Agent for the Treatment of Mild Cognitive Impairment

NMDA neurotransmission plays an important role in learning and memory. NMDA receptors were found to decrease in the frontal lobe and hippocampus of mild cognitive impairment. This study is a randomized, double-blind, placebo-controlled drug trial. All subjects will be allocated randomly to 2 groups: (1) NMDA-enhancer: DAOIB group (starting dose: 250-500 mg/d); (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

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 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 depressive disorder
  • Major physical illnesses
  • Severe visual or hearing impairment

Treatment and study plan

DAOIB

Drug

Placebo

Drug

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

Secondary outcomes

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

    Time frame: week 0, 24

  2. 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

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

    Time frame: week 0, 24

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

    Time frame: week 0, 24

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Sep 12, 2014
Registry last updated
Jan 24, 2018

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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