DementiaNCT00329706
Metabolic Cerebral Imaging in Incipient Dementia (MCI-ID)
A study testing FDG-PET brain scan in people with Dementia, run by University of California, Los Angeles at 9 sites in United States.
Trial summary
A brain PET scan is recognized as "reasonable and necessary" for some patients with "a recently established diagnosis of dementia" (Centers for Medicare and Medicaid Services, Decision Memo CAG-00088R, 2004), but evidence is less clear for patients having less severe cognitive problems. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- FDG-PET brain scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 710 participants
- Where
- 9 sitesUnited States
- Study dates
- Jun 2006to Jan 2017
- Phase
- Interventional
- 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 deficit 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 which 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 clinical relevance of the project by focusing on the age groups in whom serious concerns about early signs and symptoms of senile onset dementia are most typically emerging.
- Overt dementia, as discussed above.
- Cognitive dysfunction has impaired subject's ability to perform activities of daily living.
- Present or past history of thyroid disease (due to effects of both the disease and thyroid hormone replacement therapy on brain metabolism that we and others have begun to identify, but which remain incompletely characterized.)
- Claustrophobia or metal in body or other condition that would preclude PET or MRI from being acquired, or visual, auditory or motor deficits that would preclude accurate neuropsychological testing.
- Cholinesterase inhibition therapy already initiated.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Buffalo
Buffalo, New York, 14214
Lahey Clinic Hospital
Burlington, Massachusetts, 01805
Medical University of South Carolina
Charleston, South Carolina, 29425
Cedars-Sinai Medical Center
Los Angeles, California, 90048
UCLA Medical Center
Los Angeles, California, 90095-6942
Mayo Clinic
Phoenix, Arizona, 85054
University of Utah
Salt Lake City, Utah, 84108
Santa Monica-UCLA Medical Center
Santa Monica, California, 90404
Gene E. Myers Cardiac and Vascular Consultants
Sarasota, Florida, 34239
About this study
Official title: Early and Long-Term Value of Imaging Brain Metabolism
A brain PET scan is recognized as "reasonable and necessary" for some patients with "a recently established diagnosis of dementia" (Centers for Medicare and Medicaid Services, Decision Memo CAG-00088R, 2004), but evidence is less clear for patients having less severe cognitive problems. A substantial portion of such patients will develop Alzheimer's disease and other forms of dementia, which affect millions of people in the U.S., costing us over $100 billion annually. This project employs a prospective randomized protocol to determine whether PET scanning can help distinguish those patients with early Alzheimer's changes in their brains from those having other causes of cognitive impairment more accurately than is done with current clinical practices alone, and lead to earlier, more effective therapies which extend patients' abilities to think and function independently.
Read the detailed description
People experiencing mild cognitive changes represent an epidemiologically major segment of the geriatric patient population. In the present proposal, we aim to measure how knowledge of cerebral metabolic information 1) influences working diagnoses and management of patients being evaluated for symptoms of early cognitive decline, and 2) impacts upon long-term clinical outcomes, particularly of subjects having metabolic patterns consistent with presence of Alzheimer's disease (AD)-like changes in their brains. A total of 710 patients suffering from documentable decline of cognitive function in the absence of overt dementia will be studied at nine U.S. institutions with extensive experience and infrastructure in place for the evaluation of Alzheimer's disease and related disorders, and for neuroimaging. In this prospective, investigation, subjects will undergo baseline neuropsychologic testing and neuroimaging with MRI and FDGPET. PET scan reports will be sealed and randomized with respect to whether they are released to patients' managing physicians at the time of interpretation, or two years after the time that scanning is performed.
Working diagnoses of managing physicians will be recorded, as will the treatment decisions made by the managing physicians and their patients. Cognitive abilities, functional status, utilization of healthcare resources, and other clinical and social contact parameters will be assessed every six months. Our major hypotheses are that among patients whose PET results are immediately conveyed to their referring physicians, diagnoses and management plans will be positively affected, leading to more effective utilization of healthcare resources and to maintenance of cognitive and functional abilities at a higher level. This project will also provide a rich source of data that can be used to address questions outside of its major focus (e.g., prognostic accuracy of volumetric MRI data used instead of, or in conjunction with, FDG-PET data; incremental predictive value of applying statistically parameterizing and/or quantifying software tools to imaging data).
- Conditions
- Dementia
- Being tested
- FDG-PET brain scan
- Keywords
- mild cognitive impairment, Alzheimer's disease, dementia, FDG, PET
- Medical subject headings
- Dementia, Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG-PET brain scanProcedure or surgery
Also called [F-18]FDG PET brain scan administered once to both arms
The difference in the two arms' interventions is the time at which the FDG-PET brain scan information is available for the subjects' managing physicians. Experimental arms will have an immediate release of the PET report, while the Active Comparator arms will have a delayed release of 2 years.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Experimental arm will have an immediate release of the PET report Receives: Procedure: FDG-PET brain scan |
| 2 | Active comparator | Active Comparator arm will have a delayed release of 2 years Receives: Procedure: FDG-PET brain scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in neuropsychological (cognitive,functional) test results
Measured: baseline and 2 years
utilization of healthcare resources
Measured: baseline and 2 years
PET results, compared with working diagnoses made before and after time of PET
Measured: baseline and up to 2 years
rates of prescription of AD-specific therapies
Measured: baseline and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2006 (estimated)
- Study startJun 2006
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 710 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 H Silverman, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329706
- Sponsor's protocol ID
- 02-10-079, 03-04-026
- Status last verified
- May 2017
- First submitted
- 24 May 2006
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early and Long-Term Value of Imaging Brain Metabolism
- ClinicalTrials.gov ID
- NCT00329706
- Acronym / sponsor ID
- 02-10-079, 03-04-026
- Conditions
- Dementia
- Keywords
- mild cognitive impairment, Alzheimer's disease, dementia, FDG, PET
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 710 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services
- Study start
- Jun 2006
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 25 May 2006 (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 brain PET scan is recognized as "reasonable and necessary" for some patients with "a recently established diagnosis of dementia" (Centers for Medicare and Medicaid Services, Decision Memo CAG-00088R, 2004), but evidence is less clear for patients having less severe cognitive problems. A substantial portion of such patients will develop Alzheimer's disease and other forms of dementia, which affect millions of people in the U.S., costing us over $100 billion annually. This project employs a prospective randomized protocol to determine whether PET scanning can help distinguish those patients with early Alzheimer's changes in their brains from those having other causes of cognitive impairment more accurately than is done with current clinical practices alone, and lead to earlier, more effective therapies which extend patients' abilities to think and function independently.
Detailed description
People experiencing mild cognitive changes represent an epidemiologically major segment of the geriatric patient population. In the present proposal, we aim to measure how knowledge of cerebral metabolic information 1) influences working diagnoses and management of patients being evaluated for symptoms of early cognitive decline, and 2) impacts upon long-term clinical outcomes, particularly of subjects having metabolic patterns consistent with presence of Alzheimer's disease (AD)-like changes in their brains. A total of 710 patients suffering from documentable decline of cognitive function in the absence of overt dementia will be studied at nine U.S. institutions with extensive experience and infrastructure in place for the evaluation of Alzheimer's disease and related disorders, and for neuroimaging. In this prospective, investigation, subjects will undergo baseline neuropsychologic testing and neuroimaging with MRI and FDGPET. PET scan reports will be sealed and randomized with respect to whether they are released to patients' managing physicians at the time of interpretation, or two years after the time that scanning is performed.
Working diagnoses of managing physicians will be recorded, as will the treatment decisions made by the managing physicians and their patients. Cognitive abilities, functional status, utilization of healthcare resources, and other clinical and social contact parameters will be assessed every six months. Our major hypotheses are that among patients whose PET results are immediately conveyed to their referring physicians, diagnoses and management plans will be positively affected, leading to more effective utilization of healthcare resources and to maintenance of cognitive and functional abilities at a higher level. This project will also provide a rich source of data that can be used to address questions outside of its major focus (e.g., prognostic accuracy of volumetric MRI data used instead of, or in conjunction with, FDG-PET data; incremental predictive value of applying statistically parameterizing and/or quantifying software tools to imaging data).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: FDG-PET brain scanExperimental arm will have an immediate release of the PET report |
| 2 | Active comparator | Procedure: FDG-PET brain scanActive Comparator arm will have a delayed release of 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 deficit 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 which 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 clinical relevance of the project by focusing on the age groups in whom serious concerns about early signs and symptoms of senile onset dementia are most typically emerging.
- Overt dementia, as discussed above.
- Cognitive dysfunction has impaired subject's ability to perform activities of daily living.
- Present or past history of thyroid disease (due to effects of both the disease and thyroid hormone replacement therapy on brain metabolism that we and others have begun to identify, but which remain incompletely characterized.)
- Claustrophobia or metal in body or other condition that would preclude PET or MRI from being acquired, or 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 |
|---|---|---|
| FDG-PET brain scanAlso: [F-18]FDG PET brain scan administered once to both armsThe difference in the two arms' interventions is the time at which the FDG-PET brain scan information is available for the subjects' managing physicians. Experimental arms will have an immediate release of the PET report, while the Active Comparator arms will have a delayed release of 2 years. | Procedure or surgery | 1, 2 |
Primary outcome
change from baseline in neuropsychological (cognitive,functional) test results
Time frame: baseline and 2 years
utilization of healthcare resources
Time frame: baseline and 2 years
PET results, compared with working diagnoses made before and after time of PET
Time frame: baseline and up to 2 years
rates of prescription of AD-specific therapies
Time frame: baseline and 2 years
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 2 May 2017.
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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 H Silverman, MD, PhD principal investigator
University of California, Los Angeles
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDG-PET brain scan in people with Dementia, run by University of California, Los Angeles at 9 sites 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 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: finished, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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.
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?
change from baseline in neuropsychological (cognitive,functional) test results (time frame: baseline and 2 years). 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 2 May 2017.