Alzheimer's DiseasePhase 1NCT01609335
Normative Values for Cognitive Testing and Alzheimer's Imaging Biomarkers in Young Adults
A Phase 1 study testing F-18 FDG and C-11 PiB in people with Alzheimer's Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
Biomarkers of Alzheimer's disease (AD) occupy an essential place in recently formulated diagnostic criteria for AD where their role is to identify the pathophysiological processes underlying cognitive impairment or to predict time to dementia. Read more about this study
- Who is it for?
- Ages 30 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- F-18 FDG and C-11 PiB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Aug 2013
- 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 30 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Cognitively normal males or females aged 30 to 49 years old.
Who cannot join
- Subjects unable to lie down without moving for up to 45 minutes.
- Women who are pregnant or cannot stop breast feeding for 24 hours.
- Claustrophobic patients unable to tolerate the scans (no sedation can be offered).
- Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Normative Values for Cognitive Testing and Alzheimer's Imaging Biomarkers in Young Adults (30-49yo)
Biomarkers of Alzheimer's disease (AD) occupy an essential place in recently formulated diagnostic criteria for AD where their role is to identify the pathophysiological processes underlying cognitive impairment or to predict time to dementia. Three of these biomarkers are brain imaging tests (amyloid PET, fludeoxyglucose (FDG) PET, and structural MRI). In order to effectively use AD biomarkers for diagnostic and prognostic purposes, continuous values much be divided into normal and abnormal ranges. This requires that a cut point(s) be established in the continuous distribution of values for each biomarker.
The investigators objective in this proposal is to obtain imaging biomarker data in a group of individuals who are appropriate for establishing normative values for AD biomarkers. The investigators believe the most valid approach to establishing biomarker cut points is to base them on the upper bound of the range observed in young to early-middle-age subjects in whom the presence of occult AD pathology is extremely unlikely. Based on a large volume of community-based autopsy data, that upper age limit would be about 50 years old. The lower age bound for a group of subjects used to establish normative AD biomarker values would have to be based on considerations of brain maturation, which may continue into the middle- to late-20s. Thus, taking the above into consideration, the ideal age range for establishing normative AD imaging biomarker data (amyloid PET, FDG PET, and structural MRI) may be ages 30-49 years old.
- Conditions
- Alzheimer's Disease
- Being tested
- F-18 FDG, C-11 PiB
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-18 FDGDrug
One time intravenous administration of 17 millicurie (mCi) +/- 10%
C-11 PiBDrug
One time intravenous administration of 10-20 mCi
| Study group | Role | What they receive |
|---|---|---|
| Cognitively Normal Subjects | Other | Study participation will consist of tests of memory and thinking, a MRI, and two PET scans. F-18 FDG and C-11 Pittsburgh compound B (PiB) are two drugs used in PET scans. Receives: Drug: F-18 FDG; Drug: C-11 PiB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal values for amyloid PET, FDG and Magnetic Resonance Imaging
Biomarkers of Alzheimer's disease (AD) occupy an essential place in recently formulated diagnostic criteria for AD where their role is to identify the pathophysiological processes underlying cognitive impairment or to predict time to dementia. Three of these biomarkers are brain imaging tests (amyloid PET, FDG PET, and structural MRI). In order to effectively use AD biomarkers for diagnostic and prognostic purposes, continuous values much be divided into normal and abnormal ranges. This requires that a cut point(s) be established in the continuous distribution of values for each biomarker.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2013
- Study completionAug 2013
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 Mayo ClinicThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Val Lowe, Mayo Clinic
- Investigators
- Josie Williams, BS, Study director, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609335
- Sponsor's protocol ID
- 11-006972
- Status last verified
- Aug 2014
- First submitted
- 23 May 2012
- Last updated
- 8 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normative Values for Cognitive Testing and Alzheimer's Imaging Biomarkers in Young Adults (30-49yo)
- ClinicalTrials.gov ID
- NCT01609335
- Acronym / sponsor ID
- 11-006972
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 31 May 2012 (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.
Biomarkers of Alzheimer's disease (AD) occupy an essential place in recently formulated diagnostic criteria for AD where their role is to identify the pathophysiological processes underlying cognitive impairment or to predict time to dementia. Three of these biomarkers are brain imaging tests (amyloid PET, fludeoxyglucose (FDG) PET, and structural MRI). In order to effectively use AD biomarkers for diagnostic and prognostic purposes, continuous values much be divided into normal and abnormal ranges. This requires that a cut point(s) be established in the continuous distribution of values for each biomarker.
The investigators objective in this proposal is to obtain imaging biomarker data in a group of individuals who are appropriate for establishing normative values for AD biomarkers. The investigators believe the most valid approach to establishing biomarker cut points is to base them on the upper bound of the range observed in young to early-middle-age subjects in whom the presence of occult AD pathology is extremely unlikely. Based on a large volume of community-based autopsy data, that upper age limit would be about 50 years old. The lower age bound for a group of subjects used to establish normative AD biomarker values would have to be based on considerations of brain maturation, which may continue into the middle- to late-20s. Thus, taking the above into consideration, the ideal age range for establishing normative AD imaging biomarker data (amyloid PET, FDG PET, and structural MRI) may be ages 30-49 years old.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitively Normal Subjects | Other | Drug: F-18 FDG, Drug: C-11 PiBStudy participation will consist of tests of memory and thinking, a MRI, and two PET scans. F-18 FDG and C-11 Pittsburgh compound B (PiB) are two drugs used in PET scans. |
Who may qualify
- Ages
- 30 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Cognitively normal males or females aged 30 to 49 years old.
Key exclusion criteria (4 listed)
- Subjects unable to lie down without moving for up to 45 minutes.
- Women who are pregnant or cannot stop breast feeding for 24 hours.
- Claustrophobic patients unable to tolerate the scans (no sedation can be offered).
- Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc.
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 |
|---|---|---|
| F-18 FDGOne time intravenous administration of 17 millicurie (mCi) +/- 10% | Drug | Cognitively Normal Subjects |
| C-11 PiBOne time intravenous administration of 10-20 mCi | Drug | Cognitively Normal Subjects |
Primary outcome
Normal values for amyloid PET, FDG and Magnetic Resonance Imaging
Time frame: 2 days
Biomarkers of Alzheimer's disease (AD) occupy an essential place in recently formulated diagnostic criteria for AD where their role is to identify the pathophysiological processes underlying cognitive impairment or to predict time to dementia. Three of these biomarkers are brain imaging tests (amyloid PET, FDG PET, and structural MRI). In order to effectively use AD biomarkers for diagnostic and prognostic purposes, continuous values much be divided into normal and abnormal ranges. This requires that a cut point(s) be established in the continuous distribution of values for each biomarker.
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 8 Aug 2014.
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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.
Josie Williams, BS study director
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing F-18 FDG and C-11 PiB in people with Alzheimer's Disease, run by Mayo Clinic at 1 site in United States.
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 1 inclusion and 4 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 8 Aug 2014. 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 United States. 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. 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?
Normal values for amyloid PET, FDG and Magnetic Resonance Imaging (time frame: 2 days). 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 8 Aug 2014.