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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2007 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00544791
First Posted: October 16, 2007
Last Update Posted: October 16, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Neurim Pharmaceuticals Ltd.
Information provided by:
Assaf-Harofeh Medical Center
  Purpose

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.


Condition Intervention Phase
Mild Cognitive Impairment (MCI) Drug: melatonin Drug: placebo like melatonin tablets Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Melatonin on Memory and Other Cognitive Function in Patients Diagnosed With Mild Cognitive Impairment (MCI): A Placebo- Controlled Study.

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • a delay in cognitive decline as measured by memory tests [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Reduced MCI conversion rate to AD per year [ Time Frame: Two years ]

Estimated Enrollment: 50
Study Start Date: October 2007
Estimated Study Completion Date: October 2010
Arms Assigned Interventions
Experimental: A
melatonin 5 mg, daily dose for 6 months
Drug: melatonin
5 mg, oral, daily dose for 6 months
Placebo Comparator: B Drug: placebo like melatonin tablets

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00544791


Contacts
Contact: Michael khaigrekht, MD 972-8-9779823 khaigrekhtm@asaf.health.gov.il
Contact: Martin Rabey, MD 972-8-9779755 RabeyM@asaf.health.gov.il

Locations
Israel
Memory clinic, 'Asaf Harofeh' medical center Recruiting
Zerifin, Israel, 70300
Contact: Michael Khaigrekht, MD    972-8-9779823    Khaigrekhtm@asaf.health.gov.il   
Contact: Ran Shorer, MA    972-8-9779755    shorer@asaf.health.gov.il   
Sponsors and Collaborators
Assaf-Harofeh Medical Center
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
  More Information

ClinicalTrials.gov Identifier: NCT00544791     History of Changes
Other Study ID Numbers: 32/07
First Submitted: October 14, 2007
First Posted: October 16, 2007
Last Update Posted: October 16, 2007
Last Verified: June 2007

Keywords provided by Assaf-Harofeh Medical Center:
Mild Cognitive Impairment
Melatonin
Antioxidant
Memory
Alzheimer

Additional relevant MeSH terms:
Cognition Disorders
Mild Cognitive Impairment
Neurocognitive Disorders
Mental Disorders
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants