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

October 14, 2007
October 16, 2007
October 16, 2007
October 2007
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a delay in cognitive decline as measured by memory tests [ Time Frame: 6 months ]
Same as current
No Changes Posted
Reduced MCI conversion rate to AD per year [ Time Frame: Two years ]
Same as current
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The Effect of Melatonin on Cognitive Function in Patients Diagnosed With Mild Cognitive Impairment
The Effect of Melatonin on Memory and Other Cognitive Function in Patients Diagnosed With Mild Cognitive Impairment (MCI): A Placebo- Controlled Study.

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.

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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Mild Cognitive Impairment (MCI)
  • Drug: melatonin
    5 mg, oral, daily dose for 6 months
  • Drug: placebo like melatonin tablets
  • Experimental: A
    melatonin 5 mg, daily dose for 6 months
    Intervention: Drug: melatonin
  • Placebo Comparator: B
    Intervention: Drug: placebo like melatonin tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
October 2010
Not Provided

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.
Sexes Eligible for Study: All
55 Years to 90 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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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
Assaf-Harofeh Medical Center
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP