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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 because the information has not been verified recently.
Verified June 2007 by Assaf-Harofeh Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Neurim Pharmaceuticals Ltd.
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00544791
First received: October 14, 2007
Last updated: October 15, 2007
Last verified: June 2007
History of Changes

October 14, 2007
October 15, 2007
October 2007
Not Provided
a delay in cognitive decline as measured by memory tests [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT00544791 on ClinicalTrials.gov Archive Site
Reduced MCI conversion rate to AD per year [ Time Frame: Two years ]
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
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.
Both
55 Years to 90 Years
No
Contact: Michael khaigrekht, MD 972-8-9779823 khaigrekhtm@asaf.health.gov.il
Contact: Martin Rabey, MD 972-8-9779755 RabeyM@asaf.health.gov.il
Israel
 
NCT00544791
32/07
No
Not Provided
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