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NCT Number: NCT01600469

NMDA-enhancing Agent for Treatment of Mild Cognitive Impairment and Mild Alzheimer's Disease

NMDA activation plays an important role in learning and memory. NMDA receptors were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease and mild cognitive function impairment. This study is a randomized, double-blind, placebo-controlled drug trial. All patients will be allocated randomly to 2 groups: (1) NMDA enhancer: DAOI-B group (starting dose: 250-500 mg/d); (2) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOI-B may yield better efficacy than placebo for cognitive function in patients with mild cognitive impairment or mild Alzheimer's disease.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Mild Cognitive Impairment Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung, Taiwan, 886

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 or mild Alzheimer's
  • MMSE between 17-26
  • CDR 0.5 or 1

Exclusion criteria

  • Hachinski Ischemic Score > 4
  • substance abuse/dependence
  • Parkinson disease
  • epilepsy
  • major depressive disorder
  • dementia with psychotic features
  • major physical illnesses
  • severe visual or hearing impairment

Treatment and study plan

DAOI-B

Drug

250-1500 mg/day, oral, for 24 weeks

Placebo

Other

placebo, oral, for 24 weeks

Primary outcomes

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

    Time frame: Week 0, 8, 16, 24

Secondary outcomes

  1. Change from baseline in Mini Mental Status Examination at week 8, 16 and 24

    Time frame: Week 0, 8, 16, 24

  2. Change from baseline in Instrumental Activities of Daily Living at week 8, 16 and 24

    Time frame: Week 0, 8, 16, 24

  3. Change from baseline in Verbal learning and memory at week 24

    Time frame: Week 0, 24

  4. Change from baseline in Digit Span subtest of the Wechsler Memory Scale 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
2013
Study completion
2013
First posted
May 17, 2012
Registry last updated
Jun 4, 2013

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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