NMDA-enhancing Agent for Treatment of Mild Cognitive Impa... | NCT01600469

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

NCT01600469

Sponsor

Chang Gung Memorial Hospital

Status

Completed

Last Update Posted

Jun 4, 2013Estimated

Enrollment

86Actual

Phase

Phase 2

Conditions

Alzheimer's Disease
Mild Cognitive Impairment

Interventions

DAOI-B
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

Apr 2011

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

May 2013Actual

Completion Date

May 2013Actual

First Submitted Date

May 14, 2012

First Submission Date that Met QC Criteria

May 15, 2012

First Posted Date

May 17, 2012Estimated

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

Jun 3, 2013

Last Update Posted Date

Jun 4, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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

86Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DAOI-B	Experimental		Drug: DAOI-B
Placebo	Placebo Comparator		Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DAOI-B	Drug	250-1500 mg/day, oral, for 24 weeks	DAOI-B
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in Alzheimer's disease assessment scale-cognitive subscale in week 8, 16 and 24		Week 0, 8, 16, 24

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in Mini Mental Status Examination at week 8, 16 and 24		Week 0, 8, 16, 24
Change from baseline in Instrumental Activities of Daily Living at week 8, 16 and 24		Week 0, 8, 16, 24

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

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
Hsien-yuan Lane, MD, PhD	Departments of Psychiatry, China Medical University Hospital, Taichung, Taiwan	Study Chair

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease
D060825	Cognitive Dysfunction

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided