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
Recruitment status was Recruiting
Sponsor:
Assaf-Harofeh Medical Center
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
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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| Ages Eligible for Study: | 55 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| ClinicalTrials.gov Identifier: | NCT00544791 History of Changes |
| Other Study ID Numbers: | 32/07 |
| Study First Received: | October 14, 2007 |
| Last Updated: | October 15, 2007 |
| Health Authority: | Israel: Ethics Commission |
Keywords provided by Assaf-Harofeh Medical Center:
|
Mild Cognitive Impairment Melatonin Antioxidant Memory Alzheimer |
Additional relevant MeSH terms:
|
Cognition Disorders Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Melatonin Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on June 17, 2013