Trial Summary
What is the purpose of this trial?The purpose of this study is to evaluate change in tau PET in patients receiving anti-amyloid immunotherapies.
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
Is the drug 18F-flortaucipir promising for treating Alzheimer's disease?Yes, 18F-flortaucipir is promising for Alzheimer's disease because it helps in early and accurate diagnosis by identifying tau protein tangles, which are a key feature of the disease. This can improve understanding of the disease's progression and aid in better treatment planning.12346
What safety data exists for anti-amyloid immunotherapies in Alzheimer's treatment?The studies provided focus on the use of 18F-flortaucipir, a tau-targeted PET tracer, in Alzheimer's disease research. While they highlight its application in imaging tau pathology and its role in assessing cognitive impairment progression, they do not directly address safety data for anti-amyloid immunotherapies. The studies primarily discuss the effectiveness and application of flortaucipir in imaging and diagnosis rather than safety outcomes.13578
What data supports the idea that Anti-amyloid Immunotherapies for Alzheimer's Disease is an effective drug?The available research shows that flortaucipir, a drug used in Anti-amyloid Immunotherapies, helps track the progression of Alzheimer's disease by measuring tau protein levels in the brain. In a study with 202 participants, those with Alzheimer's showed a significant increase in tau levels over 18 months, which is linked to the disease's progression. This suggests that flortaucipir can effectively monitor changes in the brain related to Alzheimer's, although it doesn't directly show that the drug treats the disease. The research also highlights that flortaucipir is useful in predicting the near-term progression of Alzheimer's and mild cognitive impairment, which can help in managing the condition.23578
Eligibility Criteria
This trial is for people aged 50-90 with mild cognitive impairment or early Alzheimer's, confirmed by amyloid presence. They must be able to consent and fit the criteria for anti-amyloid therapy. It excludes claustrophobic individuals, those with heart rhythm issues (prolonged QT interval), anyone unable to stay still for scans, and pregnant or breastfeeding women.Inclusion Criteria
I have mild memory loss or mild Alzheimer's disease.
I am between 50 and 90 years old.
Exclusion Criteria
I cannot stay still lying down for 10 minutes.
I am not pregnant and can stop breastfeeding for 24 hours.
Treatment Details
The study tests how tau PET imaging changes in patients taking anti-amyloid immunotherapies. Tau PET uses a tracer called 18F-flortaucipir to visualize brain changes associated with Alzheimer's disease.
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment GroupExperimental Treatment1 Intervention
Subjects with a diagnosis of mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease and amyloid positive, who are starting anti-amyloid immunotherapy.
Group II: Control GroupActive Control1 Intervention
Untreated historical controls enrolled in Mayo Clinic Study of Aging (IRB 14-004401), Mayo Alzheimer's Disease Research Center (IRB 712-98), and Brain Amyloid Imaging with Pittsburgh Compound B in Normal Aging, Mild Cognitive Impairment, and Dementia (IRB 08-005553).
18F-flortaucipir is already approved in United States, European Union for the following indications:
๐บ๐ธ Approved in United States as Tauvid for:
- Diagnosis of Alzheimer's disease
๐ช๐บ Approved in European Union as Tauvid for:
- Diagnosis of Alzheimer's disease
Find a clinic near you
Research locations nearbySelect from list below to view details:
Mayo ClinicRochester, MN
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
References
18 F-flortaucipir tau positron emission tomography distinguishes established progressive supranuclear palsy from controls and Parkinson disease: A multicenter study. [2022]Label="OBJECTIVE" NlmCategory="OBJECTIVE"> 18 F-flortaucipir (formerly 18 F-AV1451 or 18 F-T807) binds to neurofibrillary tangles in Alzheimer disease, but tissue studies assessing binding to tau aggregates in progressive supranuclear palsy (PSP) have yielded mixed results. We compared in vivo 18 F-flortaucipir uptake in patients meeting clinical research criteria for PSP (n = 33) to normal controls (n = 46) and patients meeting criteria for Parkinson disease (PD; n = 26).
18F-flortaucipir (AV-1451) tau PET in frontotemporal dementia syndromes. [2021]Label="BACKGROUND">The tau positron emission tomography (PET) ligand 18F-flortaucipir binds to paired helical filaments of tau in aging and Alzheimer's disease (AD), but its utility in detecting tau aggregates in frontotemporal dementia (FTD) is uncertain.
A multicentre longitudinal study of flortaucipir (18F) in normal ageing, mild cognitive impairment and Alzheimer's disease dementia. [2022]The advent of tau-targeted PET tracers such as flortaucipir (18F) (flortaucipir, also known as 18F-AV-1451 or 18F-T807) have made it possible to investigate the sequence of development of tau in relationship to age, amyloid-ฮฒ, and to the development of cognitive impairment due to Alzheimer's disease. Here we report a multicentre longitudinal evaluation of the relationships between baseline tau, tau change and cognitive change, using flortaucipir PET imaging. A total of 202 participants 50 years old or older, including 57 cognitively normal subjects, 97 clinically defined mild cognitive impairment and 48 possible or probable Alzheimer's disease dementia patients, received flortaucipir PET scans of 20 min in duration beginning 80 min after intravenous administration of 370 MBq flortaucipir (18F). On separate days, subjects also received florbetapir amyloid PET imaging, and underwent a neuropsychological test battery. Follow-up flortaucipir scans and neuropsychological battery assessments were also performed at 9 and 18 months. Fifty-five amyloid-ฮฒ+ and 90 amyloid-ฮฒ- subjects completed the baseline and 18-month study visits and had valid quantifiable flortaucipir scans at both time points. There was a statistically significant increase in the global estimate of cortical tau burden as measured by standardized uptake value ratio (SUVr) from baseline to 18 months in amyloid-ฮฒ+ but not amyloid-ฮฒ- subjects (least squared mean change in flortaucipir SUVr : 0.0524 ยฑ 0.0085, P
Head-to-head comparison of tau positron emission tomography tracers [18F]flortaucipir and [18F]RO948. [2021]Label="PURPOSE">[18F]flortaucipir binds to paired helical filament tau and accurately identifies tau in Alzheimer's disease (AD). However, "off-target" binding interferes with the quantification of [18F]flortaucipir in several brain regions. Recently, other tau PET tracers have been developed. Here, we compare [18F]flortaucipir with the novel tau tracer [18F]RO948 head-to-head in vivo.
Comparison of regional flortaucipir PET with quantitative tau immunohistochemistry in three subjects with Alzheimer's disease pathology: a clinicopathological study. [2021]The objective of this study was to make a quantitative comparison of flortaucipir PET retention with pathological tau and ฮฒ-amyloid across a range of brain regions at autopsy.
Evaluating Alzheimer Disease With Flortaucipir and Florbetapir PET: A Clinical Case Series. [2023]Early, accurate diagnosis of Alzheimer disease (AD) is essential but remains challenging. Neuropathological hallmarks of AD are ฮฒ-amyloid neuritic plaques and tau protein neurofibrillary tangles. 18F-Florbetapir is one of several available PET tracers for imaging cortical fibrillary ฮฒ-amyloid plaques. 18F-Flortaucipir PET was recently approved for evaluating the distribution and density of aggregated neurofibrillary tangles. We present cases of mild cognitive impairment or suspected AD to depict the nuances of flortaucipir distribution and scan interpretation as well as how combined information from amyloid and tau PET may help with differential diagnosis and prognosis.
Aggregated Tau Measured by Visual Interpretation of Flortaucipir Positron Emission Tomography and the Associated Risk of Clinical Progression of Mild Cognitive Impairment and Alzheimer Disease: Results From 2 Phase III Clinical Trials. [2022]Flortaucipir positron emission tomography (PET) scans, rated with a novel, US Food and Drug Administration-approved, clinically applicable visual interpretation method, provide valuable information regarding near-term clinical progression of patients with Alzheimer disease (AD) or mild cognitive impairment (MCI).
International consensus on the use of tau PET imaging agent 18F-flortaucipir in Alzheimer's disease. [2022]Label="PURPOSE">Positron emission tomography (PET) with the first and only tau targeting radiotracer of 18F-flortaucipir approved by FDA has been increasingly used in depicting tau pathology deposition and distribution in patients with cognitive impairment. The goal of this international consensus is to help nuclear medicine practitioners procedurally perform 18F-flortaucipir PET imaging.