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The Effect of Melatonin on Cognitive Function in Patients Diagnosed With Mild Cognitive Impairment (MCI)

Primary Purpose

Mild Cognitive Impairment (MCI)

Status

Unknown status

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

melatonin

placebo like melatonin tablets

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment (MCI) focused on measuring Mild Cognitive Impairment, Melatonin, Antioxidant, Memory, Alzheimer

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Memory clinic, 'Asaf Harofeh' medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

melatonin 5 mg, daily dose for 6 months

Outcomes

Primary Outcome Measures

a delay in cognitive decline as measured by memory tests

Secondary Outcome Measures

Reduced MCI conversion rate to AD per year

Full Information

NCT ID

NCT00544791

First Posted

October 14, 2007

Last Updated

October 15, 2007

Sponsor

Assaf-Harofeh Medical Center

Collaborators

Neurim Pharmaceuticals Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00544791

Brief Title

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

Acronym

MCI

Official Title

The Effect of Melatonin on Memory and Other Cognitive Function in Patients Diagnosed With Mild Cognitive Impairment (MCI): A Placebo- Controlled Study.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2007

Overall Recruitment Status

Unknown status

Study Start Date

October 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Assaf-Harofeh Medical Center

Collaborators

Neurim Pharmaceuticals Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment (MCI)

Keywords

Mild Cognitive Impairment, Melatonin, Antioxidant, Memory, Alzheimer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

melatonin 5 mg, daily dose for 6 months

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

melatonin

Intervention Description

5 mg, oral, daily dose for 6 months

Intervention Type

Drug

Intervention Name(s)

placebo like melatonin tablets

Primary Outcome Measure Information:

Title

a delay in cognitive decline as measured by memory tests

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Reduced MCI conversion rate to AD per year

Time Frame

Two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michael khaigrekht, MD

Phone

972-8-9779823

khaigrekhtm@asaf.health.gov.il

First Name & Middle Initial & Last Name or Official Title & Degree

Martin Rabey, MD

Phone

972-8-9779755

RabeyM@asaf.health.gov.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Micheal khaigrekht, MD

Organizational Affiliation

Assaf-Harofeh medical center, Memory clinic

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Martin Rabey, MD

Organizational Affiliation

Assaf-Harofeh medical center, Neurology department

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Itzhak Sphirer, MD

Organizational Affiliation

Assaf-Harofeh medical center, sleep lab

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ran Shorer, MA

Organizational Affiliation

Asaf Harofeh medical center, Memory clinic

Official's Role

Study Chair

Facility Information:

Facility Name

Memory clinic, 'Asaf Harofeh' medical center

City

Zerifin

ZIP/Postal Code

70300

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Khaigrekht, MD

Phone

972-8-9779823

Khaigrekhtm@asaf.health.gov.il

First Name & Middle Initial & Last Name & Degree

Ran Shorer, MA

Phone

972-8-9779755

shorer@asaf.health.gov.il

12. IPD Sharing Statement

Learn more about this trial

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

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