Alzheimer's Disease Amnestic Mild Cognitive Impairment MedDRA version: 20.0 Level: HLT Classification code 10001897 Term: Alzheimer's disease (incl subtypes) System Organ Class: 100000004852
Conditions
Interventions
Product Name: [18F]PI-2620
Pharmaceutical Form: Solution for injection
INN or Proposed INN: [18F]PI-2620
CAS Number: 2173353-61-0
Other
Sponsors
Life Molecular Imaging SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria (for all subjects) • Males and females aged 50 to 90 years • Able to understand, sign and date written informed consent or having a legally authorized representative or caregiver to do it (if subject do not have the capacity to consent) • The subject has an appropriate caregiver capable of accompanying subject, if necessary • 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 salpingectomy or bilateral oophorectomy) or post-menopausal for at least 1 year (no menses for 12 months without an alternative medical cause). If they are of child-bearing potential, must commit to use of a highly effective contraceptive measure as defined by the Clinical Trial Facilitation Group for the duration of the study • Male subjects and their partners of childbearing potential must commit to the use of a highly effective method of contraception for a minimum of one week following each PET scan • Male subjects must commit to not donate sperm for a minimum of one week after each PET scan. Inclusion criteria for Non-demented control subjects • Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the [18F]PI-2620 imaging visit • Have a Mini Mental Status Examination (MMSE) score = 29 at screening • Have a Clinical Dementia Rating (CDR) score = 0 • No cognitive impairment from neuropsychological battery as judged by the investigator • A brain MRI without evidence of significant neurological pathology • Have screening NeuraCeq ([18F]florbetaben) PET imaging or prior evaluable amyloid PET imaging (in the last 12 months) demonstrating no significant amyloid binding based on qualitative analysis (visual read) • No family history of AD or neurological disease associated with dementia Inclusion criteria for subjects with aMCI • Subjects with aMCI due to AD in accordance with NIA-AA guidelines 2011 • Have a CDR score of 0.5 at screening • Have an MMSE score between 24-28 at screening • A brain MRI consistent with the possible diagnosis of AD but without other significant neurological pathologies • Have screening NeuraCeq PET imaging or prior evaluable amyloid PET imaging (in the last 12 months) demonstrating amyloid binding based on qualitative analysis (visual read) • Medications taken for symptomatic treatment of AD must be maintained on a stable dosage regimen for at least 30 days before the [18F]PI-2620 screening or follow-up visits Inclusion criteria for subjects with mild to moderate AD • Subjects with mild or moderate AD in accordance with NIA-AA guidelines 2011 • Have a CDR score of 0.5-1 (mild) or = 1 (moderate) at screening • Have an MMSE score of 22-26 (mild) or 15-21 (moderate) at screening A brain MRI consistent with the possible diagnosis of AD but without other significant neurological pathologies • Have screening NeuraCeq PET imaging or prior evaluable a
Exclusion criteria
Exclusion criteria: Exclusion Criteria (for all subjects) • Current or prior history of any alcohol or drug abuse (self-reported) • Laboratory tests with clinically significant abnormalities and/or clinically significant unstable medical illness equivalent to CTC v5.0 (common toxicity criteria) toxicities greater than grade 2 • Evidence of clinically significant disease that is expected to interfere with cognitive assessments or the ability to complete the study procedures • Subject has received an investigational drug including treatments targeting AB or tau within 3 months of screening • Prior participation in other research imaging studies resulting in radiation exposure greater than 40 mSv in aMCI and mild or moderate AD over the previous 12 months prior to screening. Prior participation in other research imaging studies in NDCs over the previous 12 months prior to screening. • Pregnant, lactating or breastfeeding • MRI exclusion criteria include: Findings of cerebrovascular disease (more than two lacunar infarcts, any territorial infarct >1 cm3, or deep white matter abnormality corresponding to an overall Fazekas scale of 3 with at least one confluent hyperintense lesion on the Fluid-Attenuated Inversion Recovery (FLAIR) sequence that is ?20 mm in any dimension), infectious disease, space-occupying lesions, normal pressure hydrocephalus or any other abnormalities associated with Central Nervous System (CNS) disease • Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI • Unwilling and/or unable to cooperate with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal study objective is to test the safety and the efficacy of a new PET tracer for tau, called [18F]PI-2620, for the detection of tau tangle accumulation in the brain of patients with mild to moderate AD, amnestic mild cognitive impairment in comparison with cognitively unimpaired healthy controls.;Secondary Objective: To evaluate the changes of tau accumulation in the brain over a time span of 17-20 months as measured with the PET tracer [18F]PI-2620, in patients with mild to moderate AD, and amnestic Mild cognitive impairment in comparison with cognitively unimpaired healthy controls.; Primary end point(s): To evaluate the safety of [18F]PI-2620 injections Cross-sectional [18F]PI-2620 PET Imaging Results at 45-75 min post injection • Visual assessment of [18F]PI-2620 tau PET scans • Compare [18F]PI-2620 SUVR in subjects with aMCI, mild to moderate AD to non-demented control subjects ; Timepoint(s) of evaluation of this end point: The study will consist of three time points: - baseline - follow-up at 6-9 months - follow-up at around 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Detection of changes in the amount of tau accumulates detected in Alzheimer's Disease patients and in amnestic Mild Cognitive Impairment, in comparison with Healthy Controls, at 6-9- and 18- months - Evaluation of the rate in the change of tau accumulates detected in Alzheimer's Disease patients and in amnestic Mild Cognitive Impairment, in comparison with Healthy Controls, at 6-9- and 18- months - Correlation between the longitudinal change in tau accumulation and the changes in cognitive tests at 6-9- and 18- month in Alzheimer's Disease patients and in amnestic Mild Cognitive Impairment - Correlattion between changes in the amount of tau accumulates detected in Alzheimer's Disease patients and in amnestic Mild Cognitive Impairment, with the changes in MRI measures at 6-9- and 18- month follow-up ; Timepoint(s) of evaluation of this end point: The study will consist of three time points: - baseline - follow-up at 6-9 months - follow-up at around 18 months | — |
Countries
United Kingdom
Contacts
Public ContactGlobal Regulatory Affairs
Life Molecular Imaging GmbH
Outcome results
None listed