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

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. Identifier: NCT00544791
Recruitment Status : Unknown
Verified June 2007 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : October 16, 2007
Last Update Posted : October 16, 2007
Neurim Pharmaceuticals Ltd.
Information provided by:
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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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.
Study Start Date : October 2007
Estimated Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory
Drug Information available for: Melatonin
U.S. FDA Resources

Arm Intervention/treatment
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

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

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

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

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.

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 identifier (NCT number): NCT00544791

Contact: Michael khaigrekht, MD 972-8-9779823
Contact: Martin Rabey, MD 972-8-9779755

Memory clinic, 'Asaf Harofeh' medical center Recruiting
Zerifin, Israel, 70300
Contact: Michael Khaigrekht, MD    972-8-9779823   
Contact: Ran Shorer, MA    972-8-9779755   
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Neurim Pharmaceuticals Ltd.
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 Identifier: NCT00544791     History of Changes
Other Study ID Numbers: 32/07
First Posted: October 16, 2007    Key Record Dates
Last Update Posted: October 16, 2007
Last Verified: June 2007

Keywords provided by Assaf-Harofeh Medical Center:
Mild Cognitive Impairment

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