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

NCT00544791 | Unknown Phase 2

• 1 other identifier: 32/07
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment (MCI)

Keywords

Mild Cognitive Impairment; Melatonin; Antioxidant; Memory; Alzheimer

Outcome Measures

Primary Outcomes (1)

• a delay in cognitive decline as measured by memory tests

  6 months

Secondary Outcomes (1)

• Reduced MCI conversion rate to AD per year

  Two years

Study Arms (2)

A

EXPERIMENTAL

melatonin 5 mg, daily dose for 6 months

Drug: melatonin

B

PLACEBO COMPARATOR

Drug: placebo like melatonin tablets

Interventions

melatonin DRUG

5 mg, oral, daily dose for 6 months

A

placebo like melatonin tablets DRUG

B

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead
• Neurim Pharmaceuticals Ltd.: collaborator

Study Sites (1)

Memory clinic, 'Asaf Harofeh' medical center

Ẕerifin, 70300, Israel

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Micheal khaigrekht, MD

  Assaf-Harofeh medical center, Memory clinic

  PRINCIPAL INVESTIGATOR

• Martin Rabey, MD

  Assaf-Harofeh medical center, Neurology department

  PRINCIPAL INVESTIGATOR

• Itzhak Sphirer, MD

  Assaf-Harofeh medical center, sleep lab

  STUDY CHAIR

• Ran Shorer, MA

  Asaf Harofeh medical center, Memory clinic

  STUDY CHAIR

Central Study Contacts

Michael khaigrekht, MD

CONTACT

972-8-9779823; khaigrekhtm@asaf.health.gov.il

Martin Rabey, MD

CONTACT

972-8-9779755; RabeyM@asaf.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: October 14, 2007
• First Posted: October 16, 2007
• Study Start: October 1, 2007
• Study Completion: October 1, 2010
• Last Updated: October 16, 2007

Record last verified: 2007-06

Locations

IL (1)