Mild Cognitive ImpairmentPhase 3NCT01028053
Assess the Prognostic Usefulness of Flutemetamol (18F) Injection for Identifying Subjects With Amnestic Mild Cognitive Impairment Who Will Convert to Clinically Probable Alzheimer's Disease
A Phase 3 study testing Flutemetamol (18F) Injection in people with Mild Cognitive Impairment and Alzheimer's Disease, run by GE Healthcare at 1 site in United States.
Trial summary
This study will investigate the efficacy of the Flutemetamol (18F) Injection PET tracer in identifying abnormal (18F) flutemetamol uptake patterns which predict the conversion from aMCI to a b-amyloid associated clinically probable Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer's Disease
- What is being tested?
- Flutemetamol (18F) Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 365 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Jan 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is 60 years old or older.
- The subject meets the Petersen criteria for amnestic MCI.
- The subject has a score of less than or equal to 4 on the Modified Hachinski Ischemic Scale.
- The subject has a MMSE score of 24-30.
- The subject has a non-contrast MRI examination as part of the screening visit that excludes aMCI arising from structural causes.
- The subject and/or the subject's legally acceptable representative, if applicable, in accordance with local regulations, has signed and dated an informed consent.
Who cannot join
- The subject has any significant neurologic disease other than suspected aMCI; such as Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumor, supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits, or known structural brain abnormalities.
- The subject has one or more aneurysm clips, artificial heart valves, metal implants, embedded metal fragments or pacemakers that would pose a risk during an MRI.
- The subject has major depression, bipolar disorder, as described in the DSM-IV within the past year.
- The subject has history of schizophrenia (DSM-IV criteria).
- The subject has had, within the prior 3 months, psychotic features, agitation or behavioral problems that could lead to protocol compliance issues.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Principal Open-label Study to Assess the Prognostic Usefulness of Flutemetamol (18F) Injection for Identifying Subjects With Amnestic Mild Cognitive Impairment Who Will Convert to Clinically Probable Alzheimer's Disease
This study will investigate the efficacy of the Flutemetamol (18F) Injection PET tracer in identifying abnormal (18F) flutemetamol uptake patterns which predict the conversion from aMCI to a b-amyloid associated clinically probable Alzheimer's disease.
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Being tested
- Flutemetamol (18F) Injection
- Keywords
- Mild Cognitive Impairment, Positron Emission Tomography, National Institute of Neurological and Communicative Disorders and Stroke, Alzheimer's Disease and Related Disorders Association, Assess Prognostic Usefulness of Flutemetamol Injection for Identifying Subjects who will Convert to Clinically Probable Alzheimer's Disease
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Communication Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flutemetamol (18F) InjectionDrug
Also called Flutemetamol, 18F
All subjects will receive an i.v. dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq.
| Study group | Role | What they receive |
|---|---|---|
| Flutemetamol (18F) Injection | Experimental | Flutemetamol (18F) Injection Receives: Drug: Flutemetamol (18F) Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hazard Ratio (HR) by PET Scan Readers for Conversion to Probable Alzheimer's Disease Based on Visual Image Interpretation.
Visual Interpretation of the PET scan by independent readers.
Note: The statistic Hazard ratio (HR) is the ratio of the hazard rates in the 2 groups (1 group being normal (negative for amyloid B) and 1 group being abnormal (positive for amyloid B). Under the null hypothesis of equal rates, the HR would be equal to 1.
As the HR increases above 1, the chances of being probable Alzheimer's Disease (pAD) also increases.
Note: Eight Subjects who withdrew prior to the first Clinical Adjudication Committee (CAC) evaluation are not included in the analysis. (232 - 8 = 224 Subjects included).
Measured: Up to 36 months post flutemetamol administration
Secondary outcomes (1)
The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer's Disease (pAD) Within the Follow up Period.
Numbers of subjects with normal and abnormal patterns of [18F]flutemetamol uptake who converted to pAD.
Measured: Up to 36 months post flutemetamol administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc., i3 Statprobe, i3 Research, Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- Paul Sherwin, M.D., Study chair, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028053
- Sponsor's protocol ID
- GE-067-005
- Status last verified
- Sep 2014
- First submitted
- 7 Dec 2009
- Last updated
- 11 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Pichet Binette A, Palmqvist S, Bali D, Farrar G, Buckley CJ, Wolk DA, Zetterberg H, Blennow K, Janelidze S, Hansson O. Combining plasma phospho-tau and accessible measures to evaluate progression to Alzheimer's dementia in mild cognitive impairment patients. Alzheimers Res Ther. 2022 Mar 29;14(1):46. doi: 10.1186/s13195-022-00990-0.
PubMed 35351181
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Principal Open-label Study to Assess the Prognostic Usefulness of Flutemetamol (18F) Injection for Identifying Subjects With Amnestic Mild Cognitive Impairment Who Will Convert to Clinically Probable Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01028053
- Acronym / sponsor ID
- GE-067-005
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Keywords
- Mild Cognitive Impairment, Positron Emission Tomography, National Institute of Neurological and Communicative Disorders and Stroke, Alzheimer's Disease and Related Disorders Association, Assess Prognostic Usefulness of Flutemetamol Injection for Identifying Subjects who will Convert to Clinically Probable Alzheimer's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc., i3 Statprobe, i3 Research, Quintiles, Inc.
- Study start
- Dec 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 9 Dec 2009 (estimated)
- Results
- Posted 11 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the efficacy of the Flutemetamol (18F) Injection PET tracer in identifying abnormal (18F) flutemetamol uptake patterns which predict the conversion from aMCI to a b-amyloid associated clinically probable Alzheimer's disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flutemetamol (18F) Injection | Experimental | Drug: Flutemetamol (18F) InjectionFlutemetamol (18F) Injection |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The subject is 60 years old or older.
- The subject meets the Petersen criteria for amnestic MCI.
- The subject has a score of less than or equal to 4 on the Modified Hachinski Ischemic Scale.
- The subject has a MMSE score of 24-30.
- The subject has a non-contrast MRI examination as part of the screening visit that excludes aMCI arising from structural causes.
Key exclusion criteria (5 listed)
- The subject has any significant neurologic disease other than suspected aMCI; such as Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumor, supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits, or known structural brain abnormalities.
- The subject has one or more aneurysm clips, artificial heart valves, metal implants, embedded metal fragments or pacemakers that would pose a risk during an MRI.
- The subject has major depression, bipolar disorder, as described in the DSM-IV within the past year.
- The subject has history of schizophrenia (DSM-IV criteria).
- The subject has had, within the prior 3 months, psychotic features, agitation or behavioral problems that could lead to protocol compliance issues.
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 |
|---|---|---|
| Flutemetamol (18F) InjectionAlso: Flutemetamol, 18FAll subjects will receive an i.v. dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq. | Drug | Flutemetamol (18F) Injection |
Primary outcome
Hazard Ratio (HR) by PET Scan Readers for Conversion to Probable Alzheimer's Disease Based on Visual Image Interpretation.
Time frame: Up to 36 months post flutemetamol administration
Visual Interpretation of the PET scan by independent readers. Note: The statistic Hazard ratio (HR) is the ratio of the hazard rates in the 2 groups (1 group being normal (negative for amyloid B) and 1 group being abnormal (positive for amyloid B). Under the null hypothesis of equal rates, the HR would be equal to 1. As the HR increases above 1, the chances of being probable Alzheimer's Disease (pAD) also increases. Note: Eight Subjects who withdrew prior to the first Clinical Adjudication Committee (CAC) evaluation are not included in the analysis. (232 - 8 = 224 Subjects included).
1 secondary outcome
The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer's Disease (pAD) Within the Follow up Period.
Time frame: Up to 36 months post flutemetamol administration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35351181Pichet Binette A, Palmqvist S, Bali D, Farrar G, Buckley CJ, Wolk DA, Zetterberg H, Blennow K, Janelidze S, Hansson O. Combining plasma phospho-tau and accessible measures to evaluate progression to Alzheimer's dementia in mild cognitive impairment patients. Alzheimers Res Ther. 2022 Mar 29;14(1):46. doi: 10.1186/s13195-022-00990-0.
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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.
Paul Sherwin, M.D. study chair
GE Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Flutemetamol (18F) Injection in people with Mild Cognitive Impairment and Alzheimer's Disease, run by GE Healthcare 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 6 inclusion and 5 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 Sep 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hazard Ratio (HR) by PET Scan Readers for Conversion to Probable Alzheimer's Disease Based on Visual Image Interpretation. (time frame: Up to 36 months post flutemetamol administration). 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 NCT01028053, which also lists 1 linked publication.
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 Sep 2014.