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

Shamir Medical Center (Assaf-Harofeh)

Status and phase: Unknown; Phase 2

Conditions: Mild Cognitive Impairment (MCI)

Treatments: Drug: placebo like melatonin tablets; Drug: melatonin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00544791

32/07

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

melatonin 5 mg, daily dose for 6 months

Treatment:

Drug: melatonin

B

Placebo Comparator group

Treatment:

Drug: placebo like melatonin tablets