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MCI

UnknownPhase 2

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.

Asset

Melatonin

Listed sites

1

Recruiting sites

1

Enrollment

50

estimated

Study population

MCI / preclinical Alzheimer’s

Key I/E criterion

•MMSE 24-30

Primary endpoint

•A delay in cognitive decline

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID32/07
NCT IDNCT00544791

Timeline

Milestones

Study start2007-10 (month precision)
Study first posted2007-10-16estimated
Last update posted2007-10-16estimated
Study completion2010-10estimated (month precision)

Assets

Drug assets

Melatonin

Study populations

Who this study enrolls

MCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age55 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition
1
Disease progression
1

Global cognition

1 endpoint
Primary/protocol endpoint

a delay in cognitive decline as measured by memory tests

Time frame:6 months

descriptive

Disease progression

1 endpoint
Secondary/protocol endpoint

Reduced MCI conversion rate to AD per year

Time frame:Two years

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.