The Effect of Melatonin on Cognitive Function in Patients... | NCT00544791

Studies
The Effect of Melatonin on Cognitive Function in Patients Diagnosed With Mild Cognitive Impairment

NCT00544791

Sponsor

Assaf-Harofeh Medical Center

Status

Unknown status

Last Update Posted

Oct 16, 2007Estimated

Enrollment

50Estimated

Phase

Phase 2

Conditions

Mild Cognitive Impairment (MCI)

Interventions

melatonin
placebo like melatonin tablets

Countries

Israel

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

Jun 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Not provided

Completion Date

Oct 2010Estimated

First Submitted Date

Oct 14, 2007

First Submission Date that Met QC Criteria

Oct 15, 2007

First Posted Date

Oct 16, 2007Estimated

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

Oct 15, 2007

Last Update Posted Date

Oct 16, 2007Estimated

Name	Class
Neurim Pharmaceuticals Ltd.	INDUSTRY

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

Recent studies have described the role of melatonin as a sleep regulator and as an anti- oxidative neuroprotective agent in improving sleep quality and delaying cognitive decline in Alzheimer's disease (AD).

In accordance with this data, our hypothesis is that melatonin will delay the cognitive decline in Mild Cognitive Impairment (MCI) patients and reduce the conversion rate from MCI to AD.

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	melatonin 5 mg, daily dose for 6 months	Drug: melatonin
B	Placebo Comparator		Drug: placebo like melatonin tablets

Interventions

Name	Type	Description	Arm Group Labels	Other Names
melatonin	Drug	5 mg, oral, daily dose for 6 months	A
placebo like melatonin tablets

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
a delay in cognitive decline as measured by memory tests		6 months

Secondary Outcomes

Measure	Description	Time Frame
Reduced MCI conversion rate to AD per year		Two years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

MCI assessment according to the Peterson et al. (2001) criteria.
Age 55-90 years, inclusive.
Study informant available.
Mini Mental Status Examination ; MMSE 24-30.
Adequate vision and hearing for neuropsychological testing.
Normal vitamin B12 level and thyroid function.

Exclusion Criteria:

Significant cerebral vascular disease (Modified Hachinski scale > 4).
Depression (Hamilton Depression Rating Scale > 12).
Central nervous system infarct, infection or focal lesions of clinical significance on CT or MRI scans.
Medical diseases or psychiatric disorders that could interfere with study participation.
Pregnant, lactating or childbearing potential.
Taking vitamin supplements or other supplements.
Restrictions on concomitant medication usage, including those with significant cholinergic or anti-cholinergic effects or potential adverse effects on cognition.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael khaigrekht, MD	Contact	972-8-9779823		khaigrekhtm@asaf.health.gov.il
Martin Rabey, MD	Contact	972-8-9779755		RabeyM@asaf.health.gov.il

Overall Officials

Name	Affiliation	Role
Micheal khaigrekht, MD	Assaf-Harofeh medical center, Memory clinic	Principal Investigator
Martin Rabey, MD	Assaf-Harofeh medical center, Neurology department	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Memory clinic, 'Asaf Harofeh' medical center	Recruiting	Ẕerifin		70300	Israel

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

Intervention Browse Module

MeSH Terms

ID	Term
D008550	Melatonin

Ancestor Terms

ID	Term
D014363	Tryptamines
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided