Mild Cognitive ImpairmentPhase 3NCT02317250
Molecular Cerebral Imaging in Incipient Dementia (MCI-ID) II
A Phase 3 study testing Amyloid imaging and FDG-PET in people with Mild Cognitive Impairment, run by University of California, Los Angeles.
Trial summary
A substantial portion of people covered by Medicare will develop Alzheimer's disease and other forms of dementia that together devastate the lives of millions of people in the United States, and cost us a total of over $200 billion every year. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Amyloid imaging and FDG-PET
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2018to Dec 2022
- Phase
- Phase 3
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Cognitive decline and/or personality change is present, as observable by physician and/or close contact(s) of the patient; or in the absence of this, the patient provides a clear history of decline that the patient's physician deems to be reliable.
- If history or neurologic exam reveals findings suspicious for stroke, tumor, bleed, ictal activity, or hydrocephalus, then CT/MRI and appropriate neurological or neurosurgical consultation must have been obtained.
- Standard history, physical, and laboratory screen have been performed to identify possible presence of depression, substance abuse, malnourishment, medication effects and interactions, cardiopulmonary compromise, electrolyte/calcium imbalance, anemia, hypoxemia, infection, thyroid dysfunction, renal dysfunction, hepatic dysfunction, or glucose dysregulation.
- Any positive findings revealed in 2) or 3) above have been appropriately treated, wherever possible, but cognitive/behavioral deficit persists post-therapy.
Who cannot join
- Subjects under age 65 will not be recruited, in order to enhance the relevance of the project by focusing on the group of Medicare beneficiaries in whom serious concerns about early signs and symptoms of senile onset dementia are most typically emerging.
- Cognitive dysfunction has impaired subject's ability to perform activities of daily living.
- Present or past history of thyroid disease.
- Claustrophobia or metal in body or other condition that would preclude PET or MRI from being acquired.
- Visual, auditory or motor deficits that would preclude accurate neuropsychological testing.
- AD-specific pharmacotherapy already initiated.
About this study
Official title: Early and Long-Term Health Outcomes of Molecular Cerebral Imaging in Incipient Dementia (MCI-ID) II
A substantial portion of people covered by Medicare will develop Alzheimer's disease and other forms of dementia that together devastate the lives of millions of people in the United States, and cost us a total of over $200 billion every year. Getting a brain scan with a PET scanner to look for abnormal brain metabolism patterns is recognized as "reasonable and necessary" for some patients with "a recently established diagnosis of dementia" (Centers for Medicare and Medicaid Services (CMS), Decision Memo CAG-00088R), but the evidence is considered less clear for patients having less severe cognitive problems, and/or for patients getting a brain scan with a PET scanner to look for abnormal proteins in the brain (CMS Decision Memo CAG-00431N). This project employs a scientifically rigorous design (prospective, multi-centered, randomized controlled trial) to determine whether such PET scanning can help distinguish more accurately than is being done in current clinical practice those patients with early molecular changes in their brains who will benefit from Alzheimer related treatments from those patients who will not, as proven by measuring to what extent the PET scans actually lead to earlier appropriate therapy, and in fact result in improved outcomes for Medicare beneficiaries and for the health care system in which they obtain care.
Read the detailed description
The overarching objective of this project is to test whether diagnostic assessments informed by data on molecular cerebral changes can lead to improved health outcomes of an epidemiologically major segment of the geriatric patient population - people experiencing changes in their cognitive skills relative to their prior level of cerebral functioning. In the present proposal, we specifically aim to measure how knowledge of molecular cerebral information 1) influences the therapeutic management of patients being evaluated for symptoms of cognitive decline, and 2) impacts upon long-term health outcomes, particularly for patients having findings on positron emission tomography (PET) scans consistent with presence of Alzheimer's disease (AD)- like changes in their brains. Patients suffering from documentable decline of cognitive function will undergo baseline neuropsychologic testing, and neuroimaging with MRI and PET. Reports of PET scans will be sealed at the time of interpretation, and then randomized with respect to whether they are released to the patients' managing physicians at the time of interpretation, or two years after the time that scanning is performed. All treatment decisions will be made by the managing physicians and their patients. Cognitive abilities, functional status, and other clinical and social history parameters will be assessed every six months. Our central hypothesis is that among the group of patients whose PET scan results are conveyed to their physicians at the time of scanning, cognitive and functional abilities will be maintained at a higher level during the two years following PET. Beyond addressing the specific aims noted above and further described below, a valuable feature of this project will be the collection of a rich source of data that can be used to address many questions beyond its major focus (e.g., diagnostic value of volumetric MRI data used instead of, or in conjunction with, PET data in the Medicare beneficiary population; incremental value of applying statistically parameterizing and/or quantifying software tools to PET data). The protocol has been designed to conform to all standards specified by the Centers for Medicare and Medicaid Services (CMS) for Coverage with Evidence Development (CED), generally, and with all requirements for a CED study responsive to CMS Decision Memo CAG-00431N, specifically.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Amyloid imaging, FDG-PET
- Keywords
- Alzheimer's disease, Alzheimer disease, MDC, Mild Decline in Cognition, MCI, Dementia, PET, FDG-PET, FDG, amyloid, amyloid imaging, CMS, Coverage with Evidence Development, CED, MCI-ID
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amyloid imagingProcedure or surgery
Amyloid imaging brain scans are administered once to all arms.
FDG-PETProcedure or surgery
[F-18] FDG-PET brain scans are administered once to all arms.
| Study group | Role | What they receive |
|---|---|---|
| prompt amyloid imaging, delayed FDG-PET | Experimental | Subject's managing physicians will be given the results of amyloid imaging scans immediately. FDG-PET results will be released two years after scanning. Receives: Procedure: Amyloid imaging; Procedure: FDG-PET |
| prompt FDG-PET, delayed amyloid imaging | Experimental | Subject's managing physicians will be given the results of FDG-PET scans immediately. Amyloid imaging results will be released two years after scanning. Receives: Procedure: Amyloid imaging; Procedure: FDG-PET |
| prompt FDG-PET, prompt amyloid imaging | Experimental | Both FDG-PET and amyloid imaging scan results will be made immediately available to the managing physician. Receives: Procedure: Amyloid imaging; Procedure: FDG-PET |
| delayed FDG-PET, delayed amyloid imaging | Active comparator | Neither FDG-PET nor amyloid imaging scan results will be released to the managing physician for 2 years. Receives: Procedure: Amyloid imaging; Procedure: FDG-PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change from baseline in neuropsychological (cognitive,functional) test results
Study participants will undergo neuropsychological testing at baseline and every six months for two years.
Measured: baseline, 6 months, 12 months, 18 months, 24 months
Utilization of healthcare resources
Measured: over 2 years
FDG-PET and amyloid imaging results, compared with working diagnoses made before and after time of imaging
Study participants will undergo FDG-PET and amyloid imaging. Working diagnoses made before and after the imaging is performed will be compared.
Measured: baseline and up to 2 years
Rates of prescription of AD-specific therapies
Comparisons between the rate of prescription for AD-specific therapies and release type (either immediate or delayed release) will be made.
Measured: baseline, 6 months, 12 months, 18 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study startJun 2018 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Study withdrawn. No participants enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services
- Responsible party
- Principal investigator, Daniel H. Silverman, University of California, Los Angeles
- Investigators
- Daniel Silverman, MD, Ph.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317250
- Sponsor's protocol ID
- 11-00815-02
- Status last verified
- Oct 2018
- First submitted
- 9 Dec 2014
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early and Long-Term Health Outcomes of Molecular Cerebral Imaging in Incipient Dementia (MCI-ID) II
- ClinicalTrials.gov ID
- NCT02317250
- Acronym / sponsor ID
- 11-00815-02
- Conditions
- Mild Cognitive Impairment
- Keywords
- Alzheimer's disease, Alzheimer disease, MDC, Mild Decline in Cognition, MCI, Dementia, PET, FDG-PET
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn. No participants enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services
- Study start
- Jun 2018 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 15 Dec 2014 (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.
A substantial portion of people covered by Medicare will develop Alzheimer's disease and other forms of dementia that together devastate the lives of millions of people in the United States, and cost us a total of over $200 billion every year. Getting a brain scan with a PET scanner to look for abnormal brain metabolism patterns is recognized as "reasonable and necessary" for some patients with "a recently established diagnosis of dementia" (Centers for Medicare and Medicaid Services (CMS), Decision Memo CAG-00088R), but the evidence is considered less clear for patients having less severe cognitive problems, and/or for patients getting a brain scan with a PET scanner to look for abnormal proteins in the brain (CMS Decision Memo CAG-00431N). This project employs a scientifically rigorous design (prospective, multi-centered, randomized controlled trial) to determine whether such PET scanning can help distinguish more accurately than is being done in current clinical practice those patients with early molecular changes in their brains who will benefit from Alzheimer related treatments from those patients who will not, as proven by measuring to what extent the PET scans actually lead to earlier appropriate therapy, and in fact result in improved outcomes for Medicare beneficiaries and for the health care system in which they obtain care.
Detailed description
The overarching objective of this project is to test whether diagnostic assessments informed by data on molecular cerebral changes can lead to improved health outcomes of an epidemiologically major segment of the geriatric patient population - people experiencing changes in their cognitive skills relative to their prior level of cerebral functioning. In the present proposal, we specifically aim to measure how knowledge of molecular cerebral information 1) influences the therapeutic management of patients being evaluated for symptoms of cognitive decline, and 2) impacts upon long-term health outcomes, particularly for patients having findings on positron emission tomography (PET) scans consistent with presence of Alzheimer's disease (AD)- like changes in their brains. Patients suffering from documentable decline of cognitive function will undergo baseline neuropsychologic testing, and neuroimaging with MRI and PET. Reports of PET scans will be sealed at the time of interpretation, and then randomized with respect to whether they are released to the patients' managing physicians at the time of interpretation, or two years after the time that scanning is performed. All treatment decisions will be made by the managing physicians and their patients. Cognitive abilities, functional status, and other clinical and social history parameters will be assessed every six months. Our central hypothesis is that among the group of patients whose PET scan results are conveyed to their physicians at the time of scanning, cognitive and functional abilities will be maintained at a higher level during the two years following PET. Beyond addressing the specific aims noted above and further described below, a valuable feature of this project will be the collection of a rich source of data that can be used to address many questions beyond its major focus (e.g., diagnostic value of volumetric MRI data used instead of, or in conjunction with, PET data in the Medicare beneficiary population; incremental value of applying statistically parameterizing and/or quantifying software tools to PET data). The protocol has been designed to conform to all standards specified by the Centers for Medicare and Medicaid Services (CMS) for Coverage with Evidence Development (CED), generally, and with all requirements for a CED study responsive to CMS Decision Memo CAG-00431N, specifically.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| prompt amyloid imaging, delayed FDG-PET | Experimental | Procedure: Amyloid imaging, Procedure: FDG-PETSubject's managing physicians will be given the results of amyloid imaging scans immediately. FDG-PET results will be released two years after scanning. |
| prompt FDG-PET, delayed amyloid imaging | Experimental | Procedure: Amyloid imaging, Procedure: FDG-PETSubject's managing physicians will be given the results of FDG-PET scans immediately. Amyloid imaging results will be released two years after scanning. |
| prompt FDG-PET, prompt amyloid imaging | Experimental | Procedure: Amyloid imaging, Procedure: FDG-PETBoth FDG-PET and amyloid imaging scan results will be made immediately available to the managing physician. |
| delayed FDG-PET, delayed amyloid imaging | Active comparator | Procedure: Amyloid imaging, Procedure: FDG-PETNeither FDG-PET nor amyloid imaging scan results will be released to the managing physician for 2 years. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Cognitive decline and/or personality change is present, as observable by physician and/or close contact(s) of the patient; or in the absence of this, the patient provides a clear history of decline that the patient's physician deems to be reliable.
- If history or neurologic exam reveals findings suspicious for stroke, tumor, bleed, ictal activity, or hydrocephalus, then CT/MRI and appropriate neurological or neurosurgical consultation must have been obtained.
- Standard history, physical, and laboratory screen have been performed to identify possible presence of depression, substance abuse, malnourishment, medication effects and interactions, cardiopulmonary compromise, electrolyte/calcium imbalance, anemia, hypoxemia, infection, thyroid dysfunction, renal dysfunction, hepatic dysfunction, or glucose dysregulation.
- Any positive findings revealed in 2) or 3) above have been appropriately treated, wherever possible, but cognitive/behavioral deficit persists post-therapy.
Key exclusion criteria (6 listed)
- Subjects under age 65 will not be recruited, in order to enhance the relevance of the project by focusing on the group of Medicare beneficiaries in whom serious concerns about early signs and symptoms of senile onset dementia are most typically emerging.
- Cognitive dysfunction has impaired subject's ability to perform activities of daily living.
- Present or past history of thyroid disease.
- Claustrophobia or metal in body or other condition that would preclude PET or MRI from being acquired.
- Visual, auditory or motor deficits that would preclude accurate neuropsychological testing.
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 |
|---|---|---|
| Amyloid imagingAmyloid imaging brain scans are administered once to all arms. | Procedure or surgery | delayed FDG-PET, delayed amyloid imaging, prompt FDG-PET, delayed amyloid imaging, prompt FDG-PET, prompt amyloid imaging, prompt amyloid imaging, delayed FDG-PET |
| FDG-PET[F-18] FDG-PET brain scans are administered once to all arms. | Procedure or surgery | delayed FDG-PET, delayed amyloid imaging, prompt FDG-PET, delayed amyloid imaging, prompt FDG-PET, prompt amyloid imaging, prompt amyloid imaging, delayed FDG-PET |
Primary outcome
Rate of change from baseline in neuropsychological (cognitive,functional) test results
Time frame: baseline, 6 months, 12 months, 18 months, 24 months
Study participants will undergo neuropsychological testing at baseline and every six months for two years.
Utilization of healthcare resources
Time frame: over 2 years
FDG-PET and amyloid imaging results, compared with working diagnoses made before and after time of imaging
Time frame: baseline and up to 2 years
Study participants will undergo FDG-PET and amyloid imaging. Working diagnoses made before and after the imaging is performed will be compared.
Rates of prescription of AD-specific therapies
Time frame: baseline, 6 months, 12 months, 18 months, 24 months
Comparisons between the rate of prescription for AD-specific therapies and release type (either immediate or delayed release) will be made.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
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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.
Daniel Silverman, MD, Ph.D. principal investigator
University of California, Los Angeles
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amyloid imaging and FDG-PET in people with Mild Cognitive Impairment, run by University of California, Los Angeles.
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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 15 Oct 2018. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rate of change from baseline in neuropsychological (cognitive,functional) test results (time frame: baseline, 6 months, 12 months, 18 months, 24 months). The study lists 4 primary outcomes in all. 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 15 Oct 2018.