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EAAT2 PET Tracer for Dementia

Phase 1 & 2
Recruiting
Led By David Wilson, MD, PhD
Research Sponsored by David Wilson
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Radial, ulnar or brachial artery suitable for catheterization
Age 40-75 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up a year
Awards & highlights

Study Summary

This trial will assess a new agent that may be able to detect Alzheimer's disease earlier than current methods.

Who is the study for?
This trial is for adults aged 40-75 with suitable arteries for catheterization, non-smokers, not on CNS drugs for three weeks, and those who can consent or have a guardian to do so. Pregnant or breastfeeding individuals and those with certain medical devices or conditions that could affect the study's outcome are excluded.Check my eligibility
What is being tested?
[18F]RP-115 PET/MRI or PET/CT along with MRI is being tested to see if it can detect early brain changes in Alzheimer's and frontotemporal dementia patients. This first-in-human study evaluates the safety and diagnostic capabilities of this new imaging agent.See study design
What are the potential side effects?
As this is a first-in-human study primarily focused on assessing safety, specific side effects of [18F]RP-115 are not yet known but will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My arm's main arteries are suitable for a catheter procedure.
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I am between 40 and 75 years old.
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I do not smoke or use nicotine replacement therapies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three years
This trial's timeline: 3 weeks for screening, Varies for treatment, and three years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Biodistribution of [18F]RP-115
Dosimetry of [18F]RP-115
Safety of Administered dose
Secondary outcome measures
[18F]RP-115 diagnostic performance

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 2C - [18F]RP-115 in patients with FTDExperimental Treatment1 Intervention
Comparison of [18F]RP-115 PET binding between AD patients and age-matched cognitively normal controls and between AD and FTD
Group II: Cohort 2B - [18F]RP-115 in patients with ADExperimental Treatment1 Intervention
Comparison of [18F]RP-115 PET binding between AD patients and age-matched cognitively normal controls and between AD and FTD
Group III: Cohort 2A - [18F]RP-115 in age-matched controlsExperimental Treatment1 Intervention
Comparison of [18F]RP-115 PET binding between AD patients and age-matched cognitively normal controls and between AD and FTD
Group IV: Cohort 1 - dosimetry of [18F]RP-115 in healthy volunteersExperimental Treatment1 Intervention
Establish [18F]RP-115 safety in the clinic with male and female PET imaging.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

David WilsonLead Sponsor
Rio pharmaceuticals Inc.UNKNOWN
David Wilson, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco

Media Library

Cohort 2C - [18F]RP-115 in patients with FTD Clinical Trial Eligibility Overview. Trial Name: NCT05374278 — Phase 1 & 2
Alzheimer's Disease Research Study Groups: Cohort 2C - [18F]RP-115 in patients with FTD, Cohort 2B - [18F]RP-115 in patients with AD, Cohort 2A - [18F]RP-115 in age-matched controls, Cohort 1 - dosimetry of [18F]RP-115 in healthy volunteers
Alzheimer's Disease Clinical Trial 2023: Cohort 2C - [18F]RP-115 in patients with FTD Highlights & Side Effects. Trial Name: NCT05374278 — Phase 1 & 2
Cohort 2C - [18F]RP-115 in patients with FTD 2023 Treatment Timeline for Medical Study. Trial Name: NCT05374278 — Phase 1 & 2

Frequently Asked Questions

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

Is this clinical experiment open to elderly subjects?

"According to the trial's entrance requirements, minimum age for participation is 40 and maximum age is 75."

Answered by AI

What is the aggregate number of participants involved in this trial?

"That is correct. Clinicaltrials.gov indicates that this medical research, which was initially shared on November 2nd 2021, has opened up registration to 68 people at a single location."

Answered by AI

Do I meet the prerequisites to participate in this trial?

"With the purpose of studying Alzheimer's disease, this clinical trial is recruiting 68 participants aged between 40 and 75. Applicants must fulfil a selection of criteria such as: being within age parameters; having an appropriate Body Mass Index (BMI); providing written informed consent or possessing someone to grant surrogate approval on their behalf; lacking any physical ailments; presenting suitable radial, ulnar, or brachial arteries for catheterization purposes; not smoking nor consuming nicotine-based products over the counter, plus avoiding central nervous system medications three weeks prior to enrollment in order to limit peripheral metabolism events; procuring a support person that spends at least five hours"

Answered by AI

Are there opportunities presently available to participate in this trial?

"According to clinicaltrials.gov, this research program is actively recruiting participants since its posting date of November 2nd 2021 and subsequent update on May 9th 2022."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
China Basin, UCSF
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Recent research and studies
~17 spots leftby Nov 2024