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    Summary
    EudraCT Number:2018-003891-11
    Sponsor's Protocol Code Number:LMT-01-02-18
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-05-30
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2018-003891-11
    A.3Full title of the trial
    An Open Label, Single Center Study, to evaluate the Safety and Imaging Characteristics of [18F]PI-2620 as PET Radioligand for Imaging Tau deposition in the brains of subjects with amnestic mild cognitive impairment (aMCI) and mild to moderate Alzheimer’s disease (AD) in comparison with non-demented controls
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of Tau depositions by brain imaging in subjects with mild cognitive impairment and mild to moderate Alzheimer’s disease in comparison with healthy controls
    A.3.2Name or abbreviated title of the trial where available
    Evaluation of Tau depositions with [18F]PI-2620 PET in aMCI and AD
    A.4.1Sponsor's protocol code numberLMT-01-02-18
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLife Molecular Imaging SA
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLife Molecular Imaging SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLife Molecular Imaging GmbH
    B.5.2Functional name of contact pointGlobal Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressTegeler Strasses 6-7
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13353
    B.5.3.4CountryGermany
    B.5.4Telephone number004930461124662
    B.5.5Fax number004930461124629
    B.5.6E-mailGRA@life-mi.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name[18F]PI-2620
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN[18F]PI-2620
    D.3.9.1CAS number 2173353-61-0
    D.3.9.3Other descriptive name2-(2-([18F]fluoro)pyridin-4-yl)-9H-pyrrolo[2,3-b:4,5-c']dipyridine
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product Yes
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alzheimer's Disease
    Amnestic Mild Cognitive Impairment
    E.1.1.1Medical condition in easily understood language
    AD is a disease beginning with subtle memory changes and can progress to Dementia. MCI is when cognitive impairment is noticeable but people are still able to perform activities of daily livings.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10001897
    E.1.2Term Alzheimer's disease (incl subtypes)
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    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.
    E.2.3Trial contains a sub-study No
    E.3Principal 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 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
    E.4Principal 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
    E.5 End points
    E.5.1Primary 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
    E.5.1.1Timepoint(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
    E.5.2Secondary 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
    E.5.2.1Timepoint(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
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients with mild to moderate Alzheimer's Disease
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    This will not be necessary, because it is a limited diagnostic application and the radiotracer will be administered by a radiographer or designated site personnel, who ascertain and document the results. Information regarding the results of the tests performed will be provided to the participants primary physician use in their care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-16
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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