Mild Cognitive Impairment (MCI)Phase 2MCINCT00544791
The Effect of Melatonin on Cognitive Function in Patients Diagnosed With Mild Cognitive Impairment
A Phase 2 study testing melatonin in people with Mild Cognitive Impairment (MCI), run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2007to Oct 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Memory clinic, 'Asaf Harofeh' medical center
Tsrifin, 70300
Michael Khaigrekht, MD, 972-8-9779823, Khaigrekhtm@asaf.health.gov.il
Ran Shorer, MA, 972-8-9779755, shorer@asaf.health.gov.il
About this study
Official title: The Effect of Melatonin on Memory and Other Cognitive Function in Patients Diagnosed With Mild Cognitive Impairment (MCI): A Placebo- Controlled Study.
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.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- melatonin, placebo like melatonin tablets
- Keywords
- Mild Cognitive Impairment, Melatonin, Antioxidant, Memory, Alzheimer
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatoninDrug
5 mg, oral, daily dose for 6 months
placebo like melatonin tabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | melatonin 5 mg, daily dose for 6 months Receives: Drug: melatonin |
| B | Placebo comparator | Not described Receives: Drug: placebo like melatonin tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
a delay in cognitive decline as measured by memory tests
Measured: 6 months
Secondary outcomes (1)
Reduced MCI conversion rate to AD per year
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startOct 2007
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Collaborators
- Neurim Pharmaceuticals Ltd.
- Investigators
- Micheal khaigrekht, MD, Principal investigator, Assaf-Harofeh medical center, Memory clinicMartin Rabey, MD, Principal investigator, Assaf-Harofeh medical center, Neurology departmentItzhak Sphirer, MD, Study chair, Assaf-Harofeh medical center, sleep labRan Shorer, MA, Study chair, Asaf Harofeh medical center, Memory clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544791
- Sponsor's protocol ID
- 32/07
- Acronym
- MCI
- Status last verified
- Jun 2007
- First submitted
- 14 Oct 2007
- Last updated
- 16 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Melatonin on Memory and Other Cognitive Function in Patients Diagnosed With Mild Cognitive Impairment (MCI): A Placebo- Controlled Study.
- ClinicalTrials.gov ID
- NCT00544791
- Acronym / sponsor ID
- MCI / 32/07
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- Mild Cognitive Impairment, Melatonin, Antioxidant, Memory, Alzheimer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Collaborators
- Neurim Pharmaceuticals Ltd.
- Study start
- Oct 2007
- Study completion
- Oct 2010 (estimated)
- First posted
- 16 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: melatoninmelatonin 5 mg, daily dose for 6 months |
| B | Placebo comparator | Drug: placebo like melatonin tablets |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| melatonin5 mg, oral, daily dose for 6 months | Drug | A |
| placebo like melatonin tablets | Drug | B |
Primary outcome
a delay in cognitive decline as measured by memory tests
Time frame: 6 months
1 secondary outcome
Reduced MCI conversion rate to AD per year
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Micheal khaigrekht, MD principal investigator
Assaf-Harofeh medical center, Memory clinic
Martin Rabey, MD principal investigator
Assaf-Harofeh medical center, Neurology department
Itzhak Sphirer, MD study chair
Assaf-Harofeh medical center, sleep lab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing melatonin in people with Mild Cognitive Impairment (MCI), run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael khaigrekht, MD (972-8-9779823, khaigrekhtm@asaf.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a delay in cognitive decline as measured by memory tests (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2007.