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PET Imaging for Alzheimer's Disease

Phase 1
Recruiting
Led By Robert B Innis, M.D.
Research Sponsored by National Institute of Mental Health (NIMH)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18 or older
Aged 18 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-2 days
Awards & highlights

Study Summary

This trial is studying a brain inflammation marker in people with neurodegenerative disorders.

Who is the study for?
This trial is for adults over 18 with neurodegenerative diseases like Alzheimer's, Parkinson's, or ALS and are in good health. It also includes healthy volunteers from specific NIMH studies. Participants must understand the study, sign consent, have no major neurological issues besides their diagnosis, not be on certain anti-inflammatory drugs or immunosuppressants recently, and can't be pregnant or HIV positive.Check my eligibility
What is being tested?
The trial tests PET imaging agents (11C-MC1, 11C-PS13, 18f-florbetaben) to measure brain inflammation in neurodegenerative disorders versus healthy individuals. It involves MRI scans and two PET scans using these agents to compare COX enzyme levels between diseased and healthy brains.See study design
What are the potential side effects?
Potential side effects may include discomfort from lying still during scans; reactions at the injection site; possible allergic reactions to the imaging agents; temporary numbness due to arterial line placement for blood draws; and exposure to radiation within safe limits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am 18 years old or older.
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I have been diagnosed with a neurodegenerative condition like Alzheimer's, Parkinson's, or Huntington's disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-2 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-2 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measure the concentration of radioligands
Secondary outcome measures
Measure the retest variability and reliability of the radioligans

Trial Design

1Treatment groups
Experimental Treatment
Group I: Only one armExperimental Treatment3 Interventions
All subjects receive the same tests
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
11C-PS13
2022
Completed Phase 2
~10

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Mental Health (NIMH)Lead Sponsor
2,776 Previous Clinical Trials
2,673,592 Total Patients Enrolled
Robert B Innis, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
27 Previous Clinical Trials
1,136 Total Patients Enrolled

Media Library

Only one arm Clinical Trial Eligibility Overview. Trial Name: NCT04396873 — Phase 1
Parkinson's Disease Research Study Groups: Only one arm
Parkinson's Disease Clinical Trial 2023: Only one arm Highlights & Side Effects. Trial Name: NCT04396873 — Phase 1
Only one arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT04396873 — Phase 1

Frequently Asked Questions

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

What is the current enrollment capacity for this clinical trial?

"Indeed, the information on clinicaltrials.gov implies that this medical study is looking to enroll volunteers. The trial was first posted on August 17th 2021 and has been updated most recently on September 29th 2022. Currently, 136 participants are sought from a single site for this endeavor."

Answered by AI

Is it possible for me to register my participation in this clinical experiment?

"This research seeks 136 participants afflicted with dementia and aged 18-99. For inclusion in the study, individuals must: be male or female; possess an understanding of the trial that allows for written informed consent to be signed (or have their LAR do so); demonstrate good general health as evidenced by medical history and physical examination; show sufficient ulnar collateral flow on a radial artery pulse check; adhere to lifestyle considerations; not suffer from cognitive impairment, already enrolled in either 01-M-0254 or 17-M-0181 studies."

Answered by AI

Has this therapeutic intervention been granted authorization by the Federal Drug Administration?

"Our team at Power has given this treatment a safety rating of 1, since it is currently in the Phase 1 trial phase and thus only possesses minimal data to support its efficacy."

Answered by AI

Are there any prior research endeavors that have explored this avenue of treatment?

"Currently, there are 7 ongoing studies that analyze this pharmaceutical with 0 Phase 3 trials. While the majority of experiments for this drug happen in Philadelphia, Pennsylvania, 9 distinct sites are executing these investigations."

Answered by AI

Is this venture a pioneering initiative?

"Currently, 7 ongoing trials are taking place in 3 cities across 2 nations regarding this particular treatment. Initially trialled by Bayer in 2010 on 161 subjects and having passed the drug-approval stage; a dozen studies have since been finished."

Answered by AI

Could individuals aged 45 or younger be considered for participation in this medical experiment?

"Eligibility for this trial is limited to those 18-99 years old. Nonetheless, there are 123 studies available for minors and 1311 trials open to seniors."

Answered by AI

Are there still vacancies for individuals to join this trial?

"Affirmative. The information hosted on clinicaltrials.gov confirms that this medical study, which was first advertised in August of 2021, is actively enrolling participants. 136 individuals are needed to join at 1 research centre."

Answered by AI

Who else is applying?

What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I watched my mother suffer through years of Alzheimer's Disease and I want to help advance the science for treating AD.
PatientReceived no prior treatments
~111 spots leftby Apr 2029