Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants
NCT ID: NCT03239561
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
15 participants
INTERVENTIONAL
2017-09-06
2018-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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[18F]MNI-1020
Participants will receive a single intravenous bolus injection of \[18F\]MNI-1020 at a dose of not more than 10 millicurie (mCi), with a maximum mass dose of 10 microgram (mcg) and maximum volume of 10 milliliter (mL) at imaging visit.
[18F]MNI-1020
Participants will receive a single intravenous bolus injection of \[18F\]MNI-1020 at a dose of not more than 10 millicurie (mCi), with a maximum mass dose of 10 microgram (mcg) and maximum volume of 10 milliliter (mL) at imaging visit.
Interventions
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[18F]MNI-1020
Participants will receive a single intravenous bolus injection of \[18F\]MNI-1020 at a dose of not more than 10 millicurie (mCi), with a maximum mass dose of 10 microgram (mcg) and maximum volume of 10 milliliter (mL) at imaging visit.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female participants must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal ligation) or post-menopausal for at least 1 year. Male participants and their partners of childbearing potential must commit to the use of two methods of contraception, one of which is a barrier method for male participants for the study duration
* Male participants must not donate sperm during the study and for 3 months after completion
Healthy Participants
* Males and females aged greater than or equal 50 years. Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the \[18F\]molecular neuroimaging (MNI)-1020 imaging visit
* Have screening \[18F\]florbetapir positron emission tomography (PET) imaging demonstrating no significant amyloid binding based on qualitative analysis (visual read)
Alzheimer Disease - Have screening \[18F\]florbetapir or prior amyloid (in the last 12 months) PET imaging demonstrating amyloid binding based on qualitative (visual read)
Exclusion Criteria
* Prior participation in other research protocols or clinical care in the last year in addition to the radiation exposure expected from participation in this clinical study, such that radiation exposure exceeds the effective dose of 50 millisievert (mSv), which would be above the acceptable annual limit established by the United States Federal Guidelines
* Unsuitable veins for repeated venipuncture
* Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, central nervous system aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in Magnetic Resonance Imaging (MRI)
Alzheimer Disease
\- Has received treatment that targeted amyloid beta or tau within the last 3 months
50 Years
ALL
Yes
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Invicro
New Haven, Connecticut, United States
Countries
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Other Identifiers
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64326067EDI0001
Identifier Type: OTHER
Identifier Source: secondary_id
CR108349
Identifier Type: -
Identifier Source: org_study_id
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