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.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00544791

Acronym

MCI

Enrollment

Registered

2007-10-16

Start date

2007-10-31

Completion date

2010-10-31

Last updated

2007-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment (MCI)

Keywords

Mild Cognitive Impairment, Melatonin, Antioxidant, Memory, Alzheimer

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.

Interventions

DRUGmelatonin

5 mg, oral, daily dose for 6 months

DRUGplacebo like melatonin tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

55 Years to 90 Years

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.

Design outcomes

Primary

Measure	Time frame
a delay in cognitive decline as measured by memory tests	6 months

Secondary

Measure	Time frame
Reduced MCI conversion rate to AD per year	Two years

Countries

Israel

Contacts

Primary ContactMichael khaigrekht, MD

khaigrekhtm@asaf.health.gov.il972-8-9779823

Backup ContactMartin Rabey, MD

RabeyM@asaf.health.gov.il972-8-9779755

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026