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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
Have been diagnosed by a neurologist or psychiatrist with MCI, ALS, PD, or an adult onset neurodegenerative dementia, such as AD (including amyloid negative subjects), FTD, corticobasal syndrome, or Huntington s disease
Must not have
Are unable to travel to the NIH
Contraindications to ketoprofen, such as hypersensitivity to ketoprofen or history of upper or lower gastrointestinal bleeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-2 days
Awards & highlights
No Placebo-Only Group

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.
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.
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 have been diagnosed with a neurodegenerative condition like Alzheimer's, Parkinson's, or Huntington's disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot travel to the NIH for treatment.
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I am allergic to ketoprofen or have had stomach or intestinal bleeding.
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I am HIV positive.
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I have never been treated with Aduhelm.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Measure the concentration of radioligands
Secondary study objectives
Measure the retest variability and reliability of the radioligans

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: Only one armExperimental Treatment3 Interventions
All subjects receive the same tests

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
2,921 Previous Clinical Trials
2,742,675 Total Patients Enrolled
25 Trials studying Dementia
7,393 Patients Enrolled for Dementia
Robert B Innis, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
27 Previous Clinical Trials
1,189 Total Patients Enrolled
2 Trials studying Dementia
121 Patients Enrolled for Dementia

Media Library

Only one arm Clinical Trial Eligibility Overview. Trial Name: NCT04396873 — Phase 1
Dementia Research Study Groups: Only one arm
Dementia 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
~105 spots leftby Apr 2029
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