What side effects are associated with this type of intervention?

The most common treatments for Primary Progressive Aphasia (PPA) often involve medications used for related neurodegenerative conditions, such as acetylcholinesterase inhibitors (e.g., donepezil, galantamine) and memantine. Acetylcholinesterase inhibitors can cause side effects like nausea, diarrhea, insomnia, muscle cramps, and fatigue. Memantine may lead to dizziness, headache, confusion, and constipation. While these treatments aim to manage symptoms, they are not specifically approved for PPA and their efficacy varies. Additionally, treatments targeting tau pathology, such as anti-tau monoclonal antibodies, are under investigation but have not yet demonstrated significant efficacy and may carry risks of infusion-related reactions and other immune responses.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Primary Progressive Aphasia (PPA). However, drugs such as cholinesterase inhibitors (donepezil, galantamine) and memantine, which are used in the treatment of Alzheimer's disease and other dementias, have shown some promise in studies for aphasia and related conditions. These treatments are being explored for their potential benefits in managing symptoms and improving language function in PPA patients.

What other types of research exist?

Promising alternatives to Tau PET Imaging for measuring tau protein accumulation in PPA patients include advanced MRI techniques such as diffusion tensor imaging (DTI) and functional MRI (fMRI), which can provide detailed information about brain structure and function. Additionally, cerebrospinal fluid (CSF) biomarkers and blood-based biomarkers are being researched for their potential to detect tau pathology non-invasively. These methods are showing promise in early detection and monitoring of neurodegenerative diseases and may become more widely available for clinical use by 2024.

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Tau PET Imaging for Frontotemporal Dementia (SLD3 Trial)

N/A

Recruiting

Led By Keith A Josephs, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must be over the age of 18

Must present with a chief complaint of progressive impairment of speech/language or changes in behavior

Must not have

All subjects with concurrent illnesses that could account for speech and language deficits, such as traumatic brain injury, strokes or developmental syndromes, and subjects meeting criteria for another neurodegenerative disease, such as amnestic Alzheimer's type dementia, dementia with Lewy bodies, progressive supranuclear palsy, and corticobasal syndrome will be excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a drug called AV-1451 to study its ability to bind to tau proteins in the brains of patients with PPA and FTD. By doing this, researchers hope to better understand tau buildup in these conditions.

Who is the study for?

This trial is for adults over 18 who primarily speak English and have progressive speech/language issues or behavior changes, fitting the criteria for Primary Progressive Aphasia or Frontotemporal Dementia. They need someone to independently assess their functioning but can't join if they have other illnesses causing similar symptoms, are pregnant/breastfeeding, mute/unintelligible speech, MRI contraindications like metal implants, severe claustrophobia, brain structure abnormalities or are on certain medications.

What is being tested?

The study tests F-18 AV 1451's ability to detect tau protein in the brain which is linked with Primary Progressive Aphasia and Frontotemporal Dementia. It aims to understand the overall tau burden in patients' brains through PET scans.

What are the potential side effects?

While not explicitly listed here, typical side effects of PET imaging agents like F-18 AV 1451 may include injection site discomfort, allergic reactions and temporary changes in taste.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 18 years old.

Select...

I am experiencing worsening problems with my speech, language, or behavior.

Select...

I have been diagnosed with Primary Progressive Aphasia or Frontotemporal Dementia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any illnesses like brain injury or Alzheimer's that affect my speech.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tau PET Scan, F-18 AV 1451Experimental Treatment1 Intervention

All subjects will receive a Tau PET scan.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Primary Progressive Aphasia (PPA) often target the underlying pathology of tau protein accumulation in the brain. Tau-targeting therapies aim to reduce or stabilize tau aggregates, which are a hallmark of neurodegenerative diseases associated with PPA. Cholinesterase inhibitors, although primarily used in Alzheimer's disease, may be trialed in PPA to improve cognitive function by increasing acetylcholine levels in the brain. Symptomatic treatments focus on managing behavioral and cognitive symptoms to improve the patient's quality of life. Understanding these mechanisms is vital for PPA patients as it helps in addressing the disease's root cause, potentially slowing its progression and enhancing daily functioning.

Tau-PET imaging with [18F]AV-1451 in primary progressive apraxia of speech.