Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00329706
Status:
COMPLETED
Last Update Posted:
2017-05-02
First Post:
2006-05-24
Brief Title:
Metabolic Cerebral Imaging in Incipient Dementia MCI-ID
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Early and Long-Term Value of Imaging Brain Metabolism
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 A substantial portion of such patients will develop Alzheimers disease and other forms of dementia which affect millions of people in the US 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 Alzheimers 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 Alzheimers 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 US institutions with extensive experience and infrastructure in place for the evaluation of Alzheimers 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 eg prognostic accuracy of volumetric MRI data used instead of or in conjunction with FDG-PET data incremental predictive value of applying statistically parameterizing andor quantifying software tools to imaging data
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 eg prognostic accuracy of volumetric MRI data used instead of or in conjunction with FDG-PET data incremental predictive value of applying statistically parameterizing andor quantifying software tools to imaging data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None