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[18F]APN-1607 PET Imaging for Alzheimer's Disease

Phase 2
Waitlist Available
Led By David Russell, M.D., Ph.D
Research Sponsored by APRINOIA Therapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males or females aged 50 to 85 years, inclusive.
No first-degree family history of early-onset AD or other neurodegenerative disease associated with dementia (prior to age 65).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 7
Awards & highlights

Study Summary

This trial is testing a new imaging technique to see if it can better detect Alzheimer's disease.

Who is the study for?
This trial is for men and women aged 50-85, who are either not able to have children or agree to use contraception. It's for those with mild to moderate Alzheimer's Disease (MDAD), AD dementia, or healthy without cognitive impairment. Participants must be in good physical health with no relevant medical issues.Check my eligibility
What is being tested?
[18F]APN-1607 uptake patterns are being compared across individuals with MDAD, AD dementia, and healthy subjects. The goal is to see how this imaging agent behaves differently among these groups which could help in understanding and diagnosing Alzheimer's Disease.See study design
What are the potential side effects?
The side effects of [18F]APN-1607 aren't detailed here but typically PET scan tracers can cause reactions at the injection site, a metallic taste in the mouth or a brief feeling of coldness from the injection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 50 and 85 years old.
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My immediate family has no history of early-onset Alzheimer's or similar diseases before 65.
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I am in good health with no significant issues found in my recent medical checks.
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I will not donate sperm during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of [18F]APN-1607 Uptake Patterns by Regional SUVR Values
Secondary outcome measures
Number of Adverse Events (AEs)
Number of Serious Adverse Events (SAEs)
Number of participants with ECG abnormalities
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: [18F]APN-1607Experimental Treatment1 Intervention
Subjects will undergo PET imaging using [18F]APN-1607.

Find a Location

Who is running the clinical trial?

APRINOIA Therapeutics, LLCLead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
Aprinoia Therapeutics Inc.Lead Sponsor
David Russell, M.D., Ph.DPrincipal InvestigatorInvicro
1 Previous Clinical Trials
3 Total Patients Enrolled

Media Library

[18F]APN-1607 Clinical Trial Eligibility Overview. Trial Name: NCT04141150 — Phase 2
Alzheimer's Disease Research Study Groups: [18F]APN-1607
Alzheimer's Disease Clinical Trial 2023: [18F]APN-1607 Highlights & Side Effects. Trial Name: NCT04141150 — Phase 2
[18F]APN-1607 2023 Treatment Timeline for Medical Study. Trial Name: NCT04141150 — Phase 2

Frequently Asked Questions

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

How many research participants are involved in this clinical trial?

"Affirmative. Clinicaltrials.gov records indicate that this clinical trial, which was first publicly posted on 19 August 2019, is currently recruiting participants. Precisely 130 individuals must be found from 1 centre of care to complete the study."

Answered by AI

Are there any vacancies available for participants in this research project?

"According to information available on clinicaltrials.gov, this medical research is currently open for enrollment. It was initially listed on August 19th 2019 and has been updated as recently as April 22nd 2022."

Answered by AI

Does participation in this trial extend to geriatric patients?

"This research necessitates that patients must be aged 50 to 85. Unfortunately, there are not a plethora of medical trials for those under 18 or over 65; only 94 and 1294 respective studies were found respectively."

Answered by AI

Is [18F]APN-1607 a viable option for patients with minimal risk?

"Our assessment of [18F]APN-1607's safety comes in at a 2, since this is still an experimental phase and there has only been data to support its safety but not efficacy."

Answered by AI

To whom is this clinical trial open for participation?

"This clinical trial aims to recruit 130 people with Alzheimer's between the ages of 50 and 85. Eligible patients must meet certain requirements, including: Females who are medically documented as surgically sterile or post-menopausal for at least one year, those of childbearing potential agreeing to use a barrier contraception method or abstain from sexual intercourse during the study period in addition to having a negative pregnancy test; willing and able to participate in all procedures; clinically healthy results on physical examination, laboratory profiles, Vital Signs (VS), Electrocardiogram (ECG) at screening and imaging visit; have a Clinical Dementia Rating score of 0"

Answered by AI

Who else is applying?

What site did they apply to?
Invicro
Columbia University Irving Center for Clinical and Translational Research (Site 105), 622 West 168th Street, PH-10th Floor
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

It is an interesting clinical trial, I would like to know if I might get Alzheimer in the near future.
PatientReceived 1 prior treatment
I'm just rather interested in helping out and learning a little bit more.And it's nice to make a little extra money on the side.Because i'm trying to do some creative projects.
PatientReceived no prior treatments
~18 spots leftby Sep 2024