Alzheimer Disease, Healthy Volunteers, Parkinson Disease
Conditions
Keywords
AD, PD, HV
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.
Interventions
DRUG[18F]MNI-1126
Florbetapir PET imaging will be completed in all healthy volunteers and AD subjects as part of the screening procedures. DaTscan SPECT imaging will be completed in those PDsubjects who have not previously had DaTscan imaging as part of the screening procedures.
Sponsors
Invicro
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
(for all subjects) * Written informed consent must be obtained before any assessment is performed. * Female subjects 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 (i.e. 12 consecutive months with no menses without an alternative medical cause) or, if they are of child-bearing potential, must commit to use two methods of contraception, one of which is a barrier method for the duration of the study. * Male subjects 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 subjects for the study duration. * Male subjects must not donate sperm for the study duration. * Willing and able to cooperate with study procedures. * For females, non-child bearing potential or negative urine pregnancy test on day of \[18F\]MNI-1126 injection. Inclusion Criteria PD subjects: * Are males or females ≥ 30 years of age. * Must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); OR either asymmetric resting tremor or asymmetric bradykinesia. * Have Hoehn and Yahr stage ≤3. * Have a MMSE score ≥ 22. * PD subjects may be treated with PD symptomatic therapy on a stable dose of medications for a period of at least 30 days prior to the \[18F\]MNI-1126 PET imaging visit. * Have screening or prior DaTscan SPECT imaging demonstrating evidence of dopamine transporter deficit based on visual read. Healthy volunteers inclusion criteria: * Males and females aged ≥50 years. Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the \[18F\]MNI-1126 imaging visit. * No cognitive impairment from neuropsychological battery as judged by the investigator. * Have screening or prior ( in the last 12 months ) amyloid PET imaging demonstrating no significant amyloid binding based on qualitative (visual read). * No family history of Alzheimer's disease or neurological disease associated with dementia. * Have a CDR global score=0. * Have an MMSE score ≥28. Inclusion criteria for subjects with a diagnosis of probable Alzheimer's disease (AD): * Males and females aged 50 to 80 years. * Have probable Alzheimer's disease dementia, based on the NINCDS/ADRDA and DSM-IV criteria, with mild severity and amnestic presentation. * Have a CDR score ≥ 0.5 at screening. * Have a MMSE score ≤ 28. * Have screening or prior (in the last 12 months) amyloid PET imaging demonstrating amyloid binding based on qualitative analysis (visual read). Amyloid PET imaging results will be shared with participants, and scans may be used by participants for future research use. * A brain MRI that supports a diagnosis of AD, with no evidence of significant neurologic pathology (see
Exclusion criteria
). * Medications taken for symptomatic treatment of AD must be maintained on a stable dosage regimen for at least 30 days before screening visit. * Signed and dated written informed consent obtained from the subject and the subject's legally authorized representative or caregiver (if applicable).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 1 year | Descriptive statistics will be applied to describe the tau deposition by region as measured by \[18F\]MNI-1126. |
Countries
United States
Outcome results
None listed