New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study - A Study to Improve Precision in Amyloid PET Coverage and Patient Care
New IDEAS: Better imaging for dementia diagnosis and care
Plain English Summary
New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study is a Not Applicable clinical trial sponsored by American College of Radiology studying Alzheimer's Disease, Dementia, Mild Cognitive Impairment. This study uses a special type of brain scan (amyloid PET) to help doctors better understand and manage dementia. It's for individuals with mild cognitive impairment or dementia who are Medicare beneficiaries. Participants will undergo an amyloid PET scan and have their health outcomes tracked over time. Alternatives include standard cognitive testing, MRI, CT scans, and cerebrospinal fluid analysis. The trial aims to enroll 6061 participants.
Official Summary
New IDEAS is an observational, open-label, longitudinal cohort study designed to address the requirements of the CED provisions of the NCD on beta-amyloid PET. Building on the initial Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) study, New IDEAS will evaluate the association between amyloid PET and patient-centered outcomes in an expanded and more ethnoracially and clinically diverse group of Medicare participants presenting with cognitive impairment.
Who Can Participate
Here is what you need to know about eligibility for this trial. You may be eligible if you are a Medicare beneficiary with mild cognitive impairment or dementia. You need to have had recent brain imaging (MRI/CT) and lab tests. You must be able to undergo the PET scan and speak English or Spanish. You cannot join if you have normal cognition, already know your amyloid status, or are in an anti-amyloid drug trial. This trial is studying Alzheimer's Disease, Dementia, Mild Cognitive Impairment, so participants generally need a confirmed diagnosis.
What They're Measuring
The study will track how health outcomes differ between patients who have amyloid buildup in their brain and those who don't, helping to guide treatment decisions. The specific primary outcome measures are: Aim 1: Health outcomes in amyloid PET-positive versus amyloid PET-negative (12 Months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial aims to improve how we use brain imaging to diagnose and treat dementia, filling a gap in precise diagnostic tools for a growing patient population. This research targets Alzheimer's Disease, Dementia, Mild Cognitive Impairment, where improved treatment options are needed.
Investor Insight
This observational study supports the use of amyloid PET scans, a growing diagnostic tool in the multi-billion dollar dementia market, with a high probability of informing future clinical practice. The large enrollment target of 6061 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if an amyloid PET scan is right for you and what it involves. Participation includes undergoing the PET scan and follow-up assessments over 12 months. Be prepared for potential travel to a PET imaging facility. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 6,061 participants
Primary Outcomes
- Aim 1: Health outcomes in amyloid PET-positive versus amyloid PET-negative (12 Months)
Secondary Outcomes
- Aim 2: Changes in patient management and health outcomes among various ethnoracial groups (12 Months)
Full Eligibility Criteria
Inclusion Criteria: * Medicare beneficiary with Medicare as primary insurance; * Meets clinical criteria for Mild Cognitive Impairment (MCI) or Dementia as defined by the 2018 National Institute on Aging - Alzheimer's Association Research Framework * Brain MRI and/or CT within 24 months prior to enrollment; * Clinical laboratory assessment (complete blood count \[CBC\], standard blood chemistry profile, thyroid stimulating hormone \[TSH\], vitamin B12) within the 12 months prior to enrollment; * Able to tolerate amyloid PET required by protocol, to be performed at a participating PET facility; * English or Spanish speaking (for the purposes of informed consent); * Willing and able to provide consent. Consent may be by proxy; * Neuropsychiatric syndrome can be classified into "clinically typical" or "clinically atypical" categories Exclusion Criteria: * Normal cognition or subjective complaints that are not verified by cognitive testing or key informant. * Knowledge of amyloid status, in the opinion of the referring dementia expert, may cause significant psychological harm or otherwise negatively impact the patient or family. * Amyloid status already known to patient or referring clinician based on prior amyloid imaging or cerebrospinal fluid analysis. * Current or previous enrollment in an anti-amyloid therapeutic trial. * Scan is being ordered solely based on a family history of dementia, presence of apolipoprotein E (ApoE) 4, or in lieu of genotyping for suspected autosomal mutation carriers. * Scan being ordered for nonmedical purposes (e.g., legal, insurance coverage, or employment screening). * Cancer requiring active therapy (excluding non-melanoma skin cancer). * Hip/pelvic fracture within the 12 months prior to enrollment. * Body weight exceeds PET scanner weight limit. * Currently pregnant or planning to become pregnant within 90 days of registration. * Life expectancy less than 24 months based on medical co-morbidities. * Residence in a skilled nursing facility (assisted living facility is not an exclusion criterion).
Trial Locations
- Full list of Active Sites and Imaging Facilities, Philadelphia, Pennsylvania, United States
Frequently Asked Questions
What is clinical trial NCT04426539?
NCT04426539 is a Not Applicable OBSERVATIONAL study titled "New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study." It is currently completed and is sponsored by American College of Radiology. The trial targets enrollment of 6061 participants.
What conditions does NCT04426539 study?
This trial investigates treatments for Alzheimer's Disease, Dementia, Mild Cognitive Impairment. The primary condition under study is Alzheimer's Disease.
What does Not Applicable mean for NCT04426539?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT04426539?
This trial is currently "Completed." It started on 2020-12-17. The estimated completion date is 2024-12-31.
Who is sponsoring NCT04426539?
NCT04426539 is sponsored by American College of Radiology. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT04426539?
The trial aims to enroll 6061 participants. The trial status is completed.
How is NCT04426539 designed?
This is a observational study.
What are the primary outcomes being measured in NCT04426539?
The primary outcome measures are: Aim 1: Health outcomes in amyloid PET-positive versus amyloid PET-negative (12 Months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT04426539 being conducted?
This trial is being conducted at 1 site, including Philadelphia, Pennsylvania (United States).
Where can I find official information about NCT04426539?
The official record for NCT04426539 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04426539. This government database provides the most up-to-date and detailed information about the trial.
What is NCT04426539 testing in simple terms?
This study uses a special type of brain scan (amyloid PET) to help doctors better understand and manage dementia. It's for individuals with mild cognitive impairment or dementia who are Medicare beneficiaries.
Why is this trial significant?
This trial aims to improve how we use brain imaging to diagnose and treat dementia, filling a gap in precise diagnostic tools for a growing patient population.
What are the potential risks of participating in NCT04426539?
The main risks are related to the PET scan procedure itself, including radiation exposure and potential allergic reactions to the tracer. Some participants may experience anxiety or distress from learning their amyloid status. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT04426539?
Ask your doctor if an amyloid PET scan is right for you and what it involves. Participation includes undergoing the PET scan and follow-up assessments over 12 months. Be prepared for potential travel to a PET imaging facility. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT04426539 signal from an investment perspective?
This observational study supports the use of amyloid PET scans, a growing diagnostic tool in the multi-billion dollar dementia market, with a high probability of informing future clinical practice. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will undergo an amyloid PET scan and have their health outcomes tracked over time. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Alzheimer's Disease Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.