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

Mild Cognitive Impairment (MCI) Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00544791
• Other study ID #: 32/07
• Status: Recruiting
• Phase: Phase 2
• First received: October 14, 2007
• Last updated: October 15, 2007
• Start date: October 2007
• Est. completion date: October 2010

Study information

• Verified date: June 2007
• Source: Assaf-Harofeh Medical Center
• Contact: Michael khaigrekht, MD
• Phone: 972-8-9779823
• Email: khaigrekhtm[@]asaf.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment
• Mild Cognitive Impairment (MCI)

Intervention

Drug:
• melatonin
5 mg, oral, daily dose for 6 months
• placebo like melatonin tablets

Locations

Country	Name	City	State
Israel	Memory clinic, 'Asaf Harofeh' medical center	Zerifin

Sponsors (2)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center	Neurim Pharmaceuticals Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a delay in cognitive decline as measured by memory tests		6 months
Secondary	Reduced MCI conversion rate to AD per year		Two years