MedDataX Logo

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

NCT ID: NCT00544791

Last Updated: 2007-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mild Cognitive Impairment (MCI)

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Mild Cognitive Impairment Melatonin Antioxidant Memory Alzheimer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

melatonin 5 mg, daily dose for 6 months

Group Type EXPERIMENTAL

melatonin

Intervention Type DRUG

5 mg, oral, daily dose for 6 months

B

Group Type PLACEBO_COMPARATOR

placebo like melatonin tablets

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

melatonin

5 mg, oral, daily dose for 6 months

Intervention Type DRUG

placebo like melatonin tablets

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Neurim Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role collaborator

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Micheal khaigrekht, MD

Role: PRINCIPAL_INVESTIGATOR

Assaf-Harofeh medical center, Memory clinic

Martin Rabey, MD

Role: PRINCIPAL_INVESTIGATOR

Assaf-Harofeh medical center, Neurology department

Itzhak Sphirer, MD

Role: STUDY_CHAIR

Assaf-Harofeh medical center, sleep lab

Ran Shorer, MA

Role: STUDY_CHAIR

Asaf Harofeh medical center, Memory clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Memory clinic, 'Asaf Harofeh' medical center

Ẕerifin, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Michael khaigrekht, MD

Role: CONTACT

Phone: 972-8-9779823

Email: [email protected]

Martin Rabey, MD

Role: CONTACT

Phone: 972-8-9779755

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Michael Khaigrekht, MD

Role: primary

Ran Shorer, MA

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

32/07

Identifier Type: -

Identifier Source: org_study_id