Alzheimer's DiseasePhase 1NCT00757939
A Study to Assess Regional Cerebral Blood Flow as an Alzheimer's Disease Biomarker Compared to Positron Emission Tomography in Patients With Mild-to-Moderate Alzheimer's Disease and Cognitively Normal Elderly Subjects (Study MK-0000-068)(COMPLETED)
A Phase 1 study testing MRI and FDG-PET in people with Alzheimer's Disease, run by Merck Sharp & Dohme LLC.
Trial summary
The aim of the study is to determine if regional cerebral blood flow, measured by dynamic arterial spin labeling (dASL), can be a biomarker for stage of Alzheimer's disease. The study is designed to be conducted in 2 parts in participants with mild to moderate Alzheimer's disease, and participants with normal… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- MRI and FDG-PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Oct 2010
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The prospective participant must meet, at least, all of the criteria below (among others determined by the study staff) to be eligible for study participation.
- The participant:
- Has mild-to-moderate Alzheimer's Disease (AD), OR is considered cognitively normal;
- Has been on stable doses of any regularly used medications for 4 weeks prior to study start;
- Must have been on a stable dose for 12 weeks prior to study start, of any medications taken for AD.
Who cannot join
- If the prospective participant meets any of the criteria below (among others determined by the study staff) they will NOT be eligible for study participation.
- The participant:
- Is living in a nursing home or skilled nursing facility;
- Has severe AD;
- Cannot undergo MRI;
- Cannot undergo PET scans;
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- Has a history of neurological or neurodegenerative disorders, other than AD within 2 years prior to study start;
- Has taken Tacrine or anti-parkinsonian medications within 3 months of study start;
- Has taken corticosteroids, blood thinners, narcotic analgesics, benzodiazepines, or certain antihistamines within 1 month of study start;
- Initiates, discontinues, or changes the dose of any AD treatment during the study.
About this study
Official title: A Two-Part Cross-Sectional and Longitudinal Study to Assess Regional Cerebral Blood Flow by Dynamic Arterial Spin Labeling as an Alzheimer's Disease Biomarker as Compared to FDG-PET in Patients With Mild-to-Moderate Alzheimer's Disease and Cognitively Normal Elderly Subjects
The aim of the study is to determine if regional cerebral blood flow, measured by dynamic arterial spin labeling (dASL), can be a biomarker for stage of Alzheimer's disease. The study is designed to be conducted in 2 parts in participants with mild to moderate Alzheimer's disease, and participants with normal cognition. Various imaging studies will be done using magnetic resonance imaging (MRI) and positron emission tomography (PET) along with neurocognitive assessments. Participants who meet the study-entry criteria will have up to 8 study visits. Repeat imaging studies may be required if the initial data are incomplete or un-interpretable. The maximum number of PET scans during the study will be limited to four.
- Conditions
- Alzheimer's Disease
- Being tested
- MRI, FDG-PET
- Keywords
- Alzheimer's Disease, MRI, PET
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
During the study all participants will have 4 total MRI scans: baseline, 1 week, 6 and 12 months.
FDG-PETOther
2 to 4 PET scans will be done over 12 months, 2 planned and 2 more if data from any of these are un-interpretable
| Study group | Role | What they receive |
|---|---|---|
| AD Participants | Experimental | Participants with a diagnosis of mild-to-moderate AD Receives: Other: MRI; Other: FDG-PET |
| Cognitively Normal Elderly Participants | Experimental | Elderly participants with no cognitive impairment Receives: Other: MRI; Other: FDG-PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional cerebral blood flow, as measured by dASL.
Part I: regional cerebral blood flow, measured by dASL at Baseline and 1 week in AD participants and cognitively normal controls. Part II: regional cerebral blood flow, measured at 6 months and 12 months in AD participants and normal control participants.
Measured: 1 week, 6 and 12 months
Secondary outcomes (2)
Rate of cerebral glucose consumption, MRglc, as measured by fludeoxyglucose-PET (FDG-PET)
Regional cerebral rate of glucose consumption, MRglc, as assessed by FDG-PET will be measured at Baseline in (Part I) and at 12 months in (Part II), in AD participants and normal control participants.
Measured: 12 months
Resting state functional MRI blood-oxygen-level-dependent (fMRI BOLD) response
The resting state fMRI BOLD (blood-oxygen-level-dependent) signal will be evaluated for 'Goodness-of-Fit' to the default mode network at Baseline, 1 week, and 6 and 12 months in AD participants and normal control participants.
Measured: 1 week, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757939
- Sponsor's protocol ID
- 0000-068
- Other IDs
- 2008_547
- Status last verified
- Aug 2015
- First submitted
- 19 Sep 2008
- Last updated
- 11 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part Cross-Sectional and Longitudinal Study to Assess Regional Cerebral Blood Flow by Dynamic Arterial Spin Labeling as an Alzheimer's Disease Biomarker as Compared to FDG-PET in Patients With Mild-to-Moderate Alzheimer's Disease and Cognitively Normal Elderly Subjects
- ClinicalTrials.gov ID
- NCT00757939
- Acronym / sponsor ID
- 0000-068
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, MRI, PET
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 23 Sep 2008 (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.
The aim of the study is to determine if regional cerebral blood flow, measured by dynamic arterial spin labeling (dASL), can be a biomarker for stage of Alzheimer's disease. The study is designed to be conducted in 2 parts in participants with mild to moderate Alzheimer's disease, and participants with normal cognition. Various imaging studies will be done using magnetic resonance imaging (MRI) and positron emission tomography (PET) along with neurocognitive assessments. Participants who meet the study-entry criteria will have up to 8 study visits. Repeat imaging studies may be required if the initial data are incomplete or un-interpretable. The maximum number of PET scans during the study will be limited to four.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AD Participants | Experimental | Other: MRI, Other: FDG-PETParticipants with a diagnosis of mild-to-moderate AD |
| Cognitively Normal Elderly Participants | Experimental | Other: MRI, Other: FDG-PETElderly participants with no cognitive impairment |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The prospective participant must meet, at least, all of the criteria below (among others determined by the study staff) to be eligible for study participation.
- Has mild-to-moderate Alzheimer's Disease (AD), OR is considered cognitively normal;
- Has been on stable doses of any regularly used medications for 4 weeks prior to study start;
- Must have been on a stable dose for 12 weeks prior to study start, of any medications taken for AD.
Key exclusion criteria (10 listed)
- If the prospective participant meets any of the criteria below (among others determined by the study staff) they will NOT be eligible for study participation.
- Is living in a nursing home or skilled nursing facility;
- Has severe AD;
- Cannot undergo MRI;
- Cannot undergo PET scans;
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 |
|---|---|---|
| MRIDuring the study all participants will have 4 total MRI scans: baseline, 1 week, 6 and 12 months. | Other | AD Participants, Cognitively Normal Elderly Participants |
| FDG-PET2 to 4 PET scans will be done over 12 months, 2 planned and 2 more if data from any of these are un-interpretable | Other | AD Participants, Cognitively Normal Elderly Participants |
Primary outcome
Regional cerebral blood flow, as measured by dASL.
Time frame: 1 week, 6 and 12 months
Part I: regional cerebral blood flow, measured by dASL at Baseline and 1 week in AD participants and cognitively normal controls. Part II: regional cerebral blood flow, measured at 6 months and 12 months in AD participants and normal control participants.
2 secondary outcomes
Rate of cerebral glucose consumption, MRglc, as measured by fludeoxyglucose-PET (FDG-PET)
Time frame: 12 months
Resting state functional MRI blood-oxygen-level-dependent (fMRI BOLD) response
Time frame: 1 week, 6 and 12 months
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 11 Aug 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MRI and FDG-PET 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?
The sponsor lists 5 inclusion and 10 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: finished, as of the sponsor's last update on 11 Aug 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Regional cerebral blood flow, as measured by dASL. (time frame: 1 week, 6 and 12 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 11 Aug 2015.