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

NCT00544791 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2007-10-16

No results posted yet for this study

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.

Conditions

  • Mild Cognitive Impairment (MCI)

Interventions

DRUG

melatonin

5 mg, oral, daily dose for 6 months

DRUG

placebo like melatonin tablets

Sponsors & Collaborators

  • Neurim Pharmaceuticals Ltd.

    collaborator INDUSTRY

  • Assaf-Harofeh Medical Center

    lead OTHER_GOV

Principal Investigators

  • Micheal khaigrekht, MD · Assaf-Harofeh medical center, Memory clinic

  • Martin Rabey, MD · Assaf-Harofeh medical center, Neurology department

  • Itzhak Sphirer, MD · Assaf-Harofeh medical center, sleep lab

  • Ran Shorer, MA · Asaf Harofeh medical center, Memory clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Completion
2010-10-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00544791 on ClinicalTrials.gov