[F-18]AV-1451-PET for Alzheimer Disease

Phase-Based Estimates
1
Effectiveness
1
Safety
UAB, Birmingham, AL
Alzheimer Disease
[F-18]AV-1451-PET - Drug
Eligibility
18+
All Sexes
Eligible conditions
Alzheimer Disease

Study Summary

This study is evaluating whether a new PET tracer can help detect tau protein in the brain.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether [F-18]AV-1451-PET will improve 1 primary outcome in patients with Alzheimer Disease. Measurement will happen over the course of 5 years.

5 years
Measurement of pathological tau deposition in the brain.

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
[F-18]AV-1451-PET/MRI

This trial requires 160 total participants across 2 different treatment groups

This trial involves 2 different treatments. [F-18]AV-1451-PET is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

[F-18]AV-1451-PET/MRI
Drug
All participants in this study will undergo a tau-PET imaging using the tracer [F-18]AV-1451 with a simultaneous PET/MRI system. The [F-18]AV-1451 dosage is 740MBq (10 mCi) given intravenously, and the PET/MRI imaging will occur 75-105 min after tracer injection.
ControlNo treatment in the control group

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 5 years for reporting.

Who is running the study

Principal Investigator
J. E. M.
Jonathan E McConathy, Director, Division of Molecular Imaging and Therapeutics
University of Alabama at Birmingham

Closest Location

UAB - Birmingham, AL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Enrollment in the UAB-ADC study under a separate IRB-approved research protocol.
Enrollment in the UAB-ADC amyloid-PET substudy under a separate IRB-approved research protocol. The amyloid-PET study does not have to have been completed prior to enrollment and participation in this tau-PET study.
Negative urine or serum hCG test within 2 days of [F-18]AV-1451 administration in women of child bearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes alzheimer disease?

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The causes of Alzheimer disease are complex, consisting of a combination of genetics, environment, and unknown factors. Although brain trauma is more common in Alzheimer disease than in other dementias, it must be distinguished from brain injury which can occur in strokes and other ways.

Unverified Answer

What is alzheimer disease?

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AD is a chronic and progressive disease characterized by cognitive, behavioural, and social-function decline that impairs social interactions. AD may cause significant suffering from the individual and their family, especially in early stages. The word Alzheimer signifies the dementia associated with Alzheimer disease.

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What are the signs of alzheimer disease?

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A detailed history will enable early diagnosis and will hopefully lessen the burden on the patient.\n\n- Anomie – the disappearance of a previously well-known social or behavioural pattern of an individual.\n- Behavioral dyscontrol – the absence of normal or natural response to common triggers, such as loud noises, a touch or an unexpected stimulus.\n- Biopsychosocial syndromes – Multiple causes, some of them biological, of psychological and behavioral problems.\n- Clinical syndromes – Symptoms of illness.\n- Diagnosis – the identification of a disorder as a particular, previously undefined condition.

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Can alzheimer disease be cured?

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AD is, and always will be, a chronic, disabling disease for which there are no known cures. The current AD treatment paradigm of early detection and pharmacotherapy has had little impact on the incidence and prevalence of the disease.

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How many people get alzheimer disease a year in the United States?

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The estimates from the NCHS for annual incidence of Alzheimer disease vary widely from 4,900 case per 100,000 in a study of Medicare beneficiaries in central California to 4,300 per 100,000 in the same population in New York State. The estimates also vary by age, sex, race/ethnicity, and education, reflecting the diversity in incidence. Estimates in the literature for the incidence of Alzheimer's in the U.S. generally have not strung together all the incidence data that has been available to date.

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What are common treatments for alzheimer disease?

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In the United States, about half of individuals with dementia are receiving medications. The most popular prescription drugs for patients with dementias are antipsychotic medications, antidepressants, anticonvulsants, and benzodiazepines. Common medications used to treat dementia-specific problems include medications for psychosis, sleep, cognitive impairments, agitation, bowel management, and anemia. Clinicians who are well versed in the medication of persons with dementia should be able to review and discuss medications that may be ineffective with dementia-related symptoms.

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What is [f-18]av-1451-pet?

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These [18]F-AV-1451 PET images agree closely with the histopathology studies. Thus, [(18)F]AV-1451 PET imaging may be useful for histological analysis and, at least in this preclinical AD model, could provide a noninvasive measure of disease activity.

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Is [f-18]av-1451-pet typically used in combination with any other treatments?

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The clinical use of [F-18]av-1451-PET as a potential treatment for dementias is currently limited to the use of this tracer as a pharmacodynamic imaging tool or as an adjunct tracer to investigate the effects of a treatment in a pharmacodynamic setting. For the most part, [F-18]av-1451-PET has not been found to change the outcomes of treatment.

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Does alzheimer disease run in families?

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Findings from a recent study do not, to our knowledge, refute the hypothesis of a genetic aetiology for AD. Rather, it seems that sporadic AD in families is the result of a combination of environmental and genetic factors.

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What is the latest research for alzheimer disease?

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Research is accelerating rapidly to address many specific questions about dementia. The research is directed toward identifying better diagnostic biomarkers and new treatments. The studies are being conducted in many countries, including the U.S. and abroad. The work is guided by a scientific model to explain the progression of dementia and other brain disorders. It is difficult for the public to understand the enormous progress in Alzheimer's research. It will be better for your brain and your future health if you follow the latest news reports about these changes in research and treatment. You can keep up to date using the latest Alzforum summaries under the Alzheimer Disease topic.

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Have there been other clinical trials involving [f-18]av-1451-pet?

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This trial has led to its early termination, although many issues concerning safety and efficacy remain in doubt. As a result, [f-18]av-1451-pet cannot be said to be fully developed, and further studies are required.

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What are the latest developments in [f-18]av-1451-pet for therapeutic use?

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At current drug doses, the treatment of Alzheimer's disease appears to be a very complicated path. Many different therapies or drugs may potentially improve the course in a clinical setting. New therapeutic strategies need to be developed in order to achieve satisfactory results in the symptomatic treatment of Alzheimer's disease.

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