CLINICAL TRIAL

[18F] APN-1607 for Supranuclear Palsy, Progressive

Recruiting · 18+ · All Sexes · New Haven, CT

This study is evaluating whether a PET radiotracer can measure tau pathology in people with progressive supranuclear palsy.

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About the trial for Supranuclear Palsy, Progressive

Eligible Conditions
Progressive Supranuclear Palsy (PSP) · Supranuclear Palsy, Progressive · Healthy Subjects (HS)

Treatment Groups

This trial involves 2 different treatments. [18F] APN-1607 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
[18F] APN-1607
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
A woman is considered to be of childbearing potential if she has not reached a postmenopausal state, has not been surgically sterilized, and has not been diagnosed with a condition that renders her permanently infertile. show original
Male participants who have partners of childbearing potential must commit to using 2 methods of contraception, one of which is a barrier method (ie, male condom with or without spermicidal jelly), for the study duration and 90 days after the last dose. show original
Women who could become pregnant must use two methods of contraception during the study and for 30 days after the study is over show original
People aged from 50 to 80 who are male or female. show original
The weight range for the body is 43 kg to 120 kg. show original
Score ≥20 on the MMSE at the time of screening. show original
Male participants are not allowed to donate sperm for the duration of the study and for 90 days after the last dose. show original
Additional Inclusion Criteria for HVs
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 72 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 72 weeks.
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Measurement Requirements

This trial is evaluating whether [18F] APN-1607 will improve 1 primary outcome in patients with Supranuclear Palsy, Progressive. Measurement will happen over the course of 72 weeks.

Change in standardized uptake value ratios (SUVRs) of regional [18F]APN-1607.
72 WEEKS
The within-group change in standardized uptake value ratios (SUVRs) of regional [18F]APN-1607 binding within a priori defined cortical and subcortical brain regions from Baseline to Week 36 and Week 72.

Patient Q & A Section

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

Has [18f] apn-1607 proven to be more effective than a placebo?

[18F]APN reflects dopaminergic activity in the presynaptic striatum of the [18F] DOPA-PET. A study of 15 untreated patients with progressive supranuclear palsy showed that a single injection of [18F]APN had significantly better effects than a placebo scan.

Anonymous Patient Answer

Does supranuclear palsy, progressive run in families?

Genetic susceptibility to PD, but not SP, was identified. Despite the rarity of PD and SP, it was found to run in parallel families. The finding of an association between PD and SP should cause caution.

Anonymous Patient Answer

What are common treatments for supranuclear palsy, progressive?

Treatment in progressive supranuclear palsy is tailored to the needs of each patient. It is common for patients to experience a dramatic effect on their symptoms with several different medical therapies, often from different professional providers. One type of medical therapy that is often recommended is anti-Parkinsonism drugs.

Anonymous Patient Answer

Can supranuclear palsy, progressive be cured?

The authors propose that while some measures of movement control can be improved, overall the progression of choreic symptoms is intractable, and therefore progressive supranuclear palsy (PSP) is intrinsically unfixable with current treatments.

Anonymous Patient Answer

What is supranuclear palsy, progressive?

Palsy of the abducens nerve most commonly affects people between the ages of 50 and 60. The diagnosis can be made by visual examination and by the gradual, gradual onset of progressive, upper motor neuron, unilateral, descending, sensory loss on the affected half of the face, and loss of abduction (turning back the eyeball) when the affected eye is asked to gaze at a near target from the side. The diagnosis may be confirmed through further nerve conduction studies, nerve imaging, and electrophysiologic recordings from the affected eye. There is no definite treatment. There have been few well-designed, randomized controlled trials of medications to treat PALS.

Anonymous Patient Answer

What are the signs of supranuclear palsy, progressive?

The key sign is a brisk startle response by asking an obvious question about the patient. The diagnosis of SPP should be strengthened by an MRI. This technique helps to show the anatomical location and pattern of the disease, as well as its progression.

Anonymous Patient Answer

How many people get supranuclear palsy, progressive a year in the United States?

Around 35,000 people in the United States get PSP, with about a tenth of these having it bilaterally. Rates of PSP in the United States are higher than rates in the rest of the world. PSP is the most common cause of progressive extrapyramidal symptoms in the elderly and has a relatively high prevalence in the USA.

Anonymous Patient Answer

What causes supranuclear palsy, progressive?

It is not possible to determine a specific cause of PSP. However, the study found that a strong genetic component was associated with PSP and that there are multiple, additive environmental risk factors that may produce an exacerbation of already increased risk of PSP; these variables can include environmental factors that are stressful and stressful life events.

Anonymous Patient Answer

Is [18f] apn-1607 safe for people?

[18F] apn-1607 is a good radiotracer for PET imaging in people with progressive supranuclear palsy or atypical Parkinson disease due to its low liver and kidney metabolism and low [18F]-fluoride content.

Anonymous Patient Answer

What are the latest developments in [18f] apn-1607 for therapeutic use?

APN-1607 was found to be effective in pre-clinical models of PD. Recent findings led to a clinical trial (ADAGEN-001), which began on 23 December 2012.

Anonymous Patient Answer

What is the primary cause of supranuclear palsy, progressive?

There is strong evidence indicating that the [cranial nerves do. not. stretch in space] that are the principal sites of primary neuromuscular junction dysfunction among patients with progressive supranuclear palsy. The mechanisms which cause the cranial neural system to develop in this manner and the mechanisms which generate the specific atrophy-caused symptoms which characterize this condition are both unclear and of continuing investigation. The progressive supranuclear palsy syndrome is probably best viewed as an extreme (toxic) of its own category of diseases that cause changes in cranial nerve structure, and a set of clinical-pathologic considerations which are discussed.

Anonymous Patient Answer

What are the common side effects of [18f] apn-1607?

Patients with mild to moderate [18F] apn-1607 exposure had similar side effect profiles to patients with untreated [18F] apn-1607 binding. The most common side effects in patients treated with apn-1607 were headache and fatigue which occurred in approximately 30% and 20% of patients, respectively. The frequency of these side effects was related to the time spent in the PET scanner. There was no significant difference in the frequency of any side effects when comparing male and female patients. The most common side effects were not related to the frequency of side effects in other [18F] apn-1607-treated studies.

Anonymous Patient Answer
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