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

Phase 2

• Conditions: Mild Cognitive Impairment (MCI)
• Interventions: Drug: placebo like melatonin tablets; Drug: melatonin

• Registration Number: NCT00544791
• Lead Sponsor: Assaf-Harofeh Medical Center

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 available

Study Timeline

• Status Verified: 2007-06
• Study Start: 2007-10
• Study First Submitted: 2007-10-14
• Study First Submitted QC: 2007-10-15
• Last Update Submitted: 2007-10-15
• Study First Posted: 2007-10-16
• Last Update Posted: 2007-10-16
• Study Completion: 2010-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	placebo like melatonin tablets	-
A	melatonin	melatonin 5 mg, daily dose for 6 months

Primary Outcome Measures

Name	Time	Method
a delay in cognitive decline as measured by memory tests	6 months

Secondary Outcome Measures

Name	Time	Method
Reduced MCI conversion rate to AD per year	Two years

Trial Locations

Locations (1)

Memory clinic, 'Asaf Harofeh' medical center; 🇮🇱 Zerifin, Israel