Evaluation of [18F]MNI-1126 as an Imaging Marker for Synaptic Density Loss in the Brain of Patients With Probable Alzheimer's Disease, Probable Parkinson's Disease (PD) Subjects as Compared to Healthy Volunteers (HV).
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Invicro
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Regions in the VOI template will be used to quantify the regional tracer uptake and used for comparison of potential uptake differences across the different groups.
Overview
Brief Summary
The primary objective of this protocol is to examine [18F]MNI-1126 as a tool to assess synaptic density loss.
Detailed Description
The primary objective of this protocol is to examine [18F]MNI-1126 as a tool to assess synaptic density loss.The specific objectives are:
- Examine [18F]MNI-1126 as a tool to assess synaptic density loss.
- To measure the dynamic uptake and washout of [18F]MNI-1126 in the brain using positron emission tomography (PET) in subjects with AD, PD, and healthy volunteers.
- To measure blood metabolites of [18F]MNI-1126 and perform kinetic modeling to assess its ability to measure synaptic density loss in the brain using the tracer plasma concentration or a reference region as indirect input.
- To acquire safety data following injection of [18F]MNI-1126.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
[18F]MNI-1126
To measure the dynamic uptake and washout of [18F]MNI-1126 in the brain using positron emission tomography (PET) in subjects with AD, PD, and healthy volunteers.
Intervention: [18F]MNI-1126 (Drug)
Outcomes
Primary Outcomes
Regions in the VOI template will be used to quantify the regional tracer uptake and used for comparison of potential uptake differences across the different groups.
Time Frame: 1 year
Descriptive statistics will be applied to describe the tau deposition by region as measured by \[18F\]MNI-1126.
Secondary Outcomes
No secondary outcomes reported