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

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

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.

Study Overview

• Status: Unknown
• Conditions: Mild Cognitive Impairment (MCI)
• Intervention / Treatment: Drug: melatonin; Drug: placebo like melatonin tablets

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Zerifin, Israel, 70300
    • Recruiting
    • Memory clinic, 'Asaf Harofeh' medical center
    • Contact: Michael Khaigrekht, MD; Phone Number: 972-8-9779823; Email: Khaigrekhtm@asaf.health.gov.il
    • Contact: Ran Shorer, MA; Phone Number: 972-8-9779755; Email: shorer@asaf.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: B	Drug: placebo like melatonin tablets
Experimental: A; melatonin 5 mg, daily dose for 6 months	Drug: melatonin; 5 mg, oral, daily dose for 6 months

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center
• Collaborators: Neurim Pharmaceuticals Ltd.
• Investigators: Principal Investigator: Micheal khaigrekht, MD, Assaf-Harofeh medical center, Memory clinic; Principal Investigator: Martin Rabey, MD, Assaf-Harofeh medical center, Neurology department; Study Chair: Itzhak Sphirer, MD, Assaf-Harofeh medical center, sleep lab; Study Chair: Ran Shorer, MA, Asaf Harofeh medical center, Memory clinic

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion: December 7, 2022
• Study Completion (Anticipated): October 1, 2010

Study Registration Dates

• First Submitted: October 14, 2007
• First Submitted That Met QC Criteria: October 15, 2007
• First Posted (Estimate): October 16, 2007

Study Record Updates

• Last Update Posted (Estimate): October 16, 2007
• Last Update Submitted That Met QC Criteria: October 15, 2007
• Last Verified: June 1, 2007

More Information

Terms related to this study

• Keywords: Melatonin; Mild Cognitive Impairment; Alzheimer; Memory; Antioxidant
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: 32/07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No