NMDA-enhancing Agent for the Treatment of Mild Cognitive... | NCT02239003

Studies
NMDA-enhancing Agent for the Treatment of Mild Cognitive Impairment

NCT02239003

Sponsor

Chang Gung Memorial Hospital

Status

Completed

Last Update Posted

Jan 24, 2018Actual

Enrollment

24Actual

Phase

Phase 2

Conditions

Mild Cognitive Impairment

Interventions

DAOIB
Placebo

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Oct 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

Sep 9, 2014

First Submission Date that Met QC Criteria

Sep 10, 2014

First Posted Date

Sep 12, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2018

Last Update Posted Date

Jan 24, 2018Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DAOIB	Experimental	250-1500 mg/day, oral, for 24 weeks	Drug: DAOIB
Placebo	Placebo Comparator	placebo, oral, for 24 weeks	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DAOIB	Drug		DAOIB
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chieh-Hsin Lin, MD, PhD	Chang Gung Memorial Hospital	Principal Investigator
Hsien-Yuan Lane, MD, PhD	China Medical University, China	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaohsiung Chang Gung Memorial Hospital		Kaohsiung City		886	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D060825	Cognitive Dysfunction

Ancestor Terms

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided