NCT02239003

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 24, 2018

Status Verified

January 1, 2018

Enrollment Period

5.8 years

First QC Date

September 9, 2014

Last Update Submit

January 23, 2018

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

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

    week 0, 8, 16, 24

Secondary Outcomes (4)

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

    week 0, 24

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

    week 8, 16, 24

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

    week 0, 24

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

    week 0, 24

Study Arms (2)

DAOIB

EXPERIMENTAL

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

Drug: DAOIB

Placebo

PLACEBO COMPARATOR

placebo, oral, for 24 weeks

Drug: Placebo

Interventions

DAOIBDRUG
DAOIB
PlaceboDRUG
Placebo

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of mild cognitive impairment
  • MMSE between 17-26
  • CDR 0.5

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 886, Taiwan

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Chieh-Hsin Lin, MD, PhD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

  • Hsien-Yuan Lane, MD, PhD

    China Medical University, China

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 9, 2014

First Posted

September 12, 2014

Study Start

January 1, 2012

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

January 24, 2018

Record last verified: 2018-01

Locations

TW(1)