Alzheimer's DiseasePhase 2NCT00074529
Study of MK0677 for the Treatment of Alzheimer's Disease (0677-030)(COMPLETED)
A Phase 2 study testing MK0677 in people with Alzheimer's Disease, run by Merck Sharp & Dohme LLC.
Trial summary
An investigational drug (MK0677) will be studied to determine whether it helps the memory and cognition of patients with Alzheimer's Disease. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- MK0677
- How many people
- 512 participants
- Where
- No sites listed yet
- Study dates
- Oct 2003to Jan 2006
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Patients must have probable Alzheimer's disease of mild or moderate severity.
- A brain scan and laboratory results must be consistent with Alzheimer's disease.
- The patient must be otherwise medically healthy.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of MK-0677 25 mg in Slowing the Progression of Alzheimer's Disease
An investigational drug (MK0677) will be studied to determine whether it helps the memory and cognition of patients with Alzheimer's Disease.
- Conditions
- Alzheimer's Disease
- Being tested
- MK0677
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0677Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function over 12 month period; safety and tolerability
Measured: over 12 month period
Secondary outcomes (1)
AD symptoms over a 6 month and 12 month period measured by the CIBIC + and the ADAS-Cog.
Measured: over a 6 month and 12 month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2003 (estimated)
- Study startOct 2003
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00074529
- Sponsor's protocol ID
- 0677-030
- Other IDs
- Formally-BG0812AZ, MK0677-030, 2006_412
- Status last verified
- Jul 2015
- First submitted
- 15 Dec 2003
- Last updated
- 24 Jul 2015
- Results posted
- No
Publications
Sevigny JJ, Ryan JM, van Dyck CH, Peng Y, Lines CR, Nessly ML; MK-677 Protocol 30 Study Group. Growth hormone secretagogue MK-677: no clinical effect on AD progression in a randomized trial. Neurology. 2008 Nov 18;71(21):1702-8. doi: 10.1212/01.wnl.0000335163.88054.e7.
PubMed 19015485Sevigny JJ, Peng Y, Liu L, Lines CR. Item analysis of ADAS-Cog: effect of baseline cognitive impairment in a clinical AD trial. Am J Alzheimers Dis Other Demen. 2010 Mar;25(2):119-24. doi: 10.1177/1533317509350298.
PubMed 19949163
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of MK-0677 25 mg in Slowing the Progression of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00074529
- Acronym / sponsor ID
- 0677-030
- Conditions
- Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 16 Dec 2003 (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.
An investigational drug (MK0677) will be studied to determine whether it helps the memory and cognition of patients with Alzheimer's Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| MK0677 | Drug | – |
Primary outcome
Cognitive function over 12 month period; safety and tolerability
Time frame: over 12 month period
1 secondary outcome
AD symptoms over a 6 month and 12 month period measured by the CIBIC + and the ADAS-Cog.
Time frame: over a 6 month and 12 month period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2015.
- Background: PubMed 19015485Sevigny JJ, Ryan JM, van Dyck CH, Peng Y, Lines CR, Nessly ML; MK-677 Protocol 30 Study Group. Growth hormone secretagogue MK-677: no clinical effect on AD progression in a randomized trial. Neurology. 2008 Nov 18;71(21):1702-8. doi: 10.1212/01.wnl.0000335163.88054.e7.
- Derived from this study: PubMed 19949163Sevigny JJ, Peng Y, Liu L, Lines CR. Item analysis of ADAS-Cog: effect of baseline cognitive impairment in a clinical AD trial. Am J Alzheimers Dis Other Demen. 2010 Mar;25(2):119-24. doi: 10.1177/1533317509350298.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MK0677 in people with Alzheimer's Disease, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 24 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function over 12 month period; safety and tolerability (time frame: over 12 month period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00074529, which also lists 2 linked publications.
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 24 Jul 2015.