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    Summary
    EudraCT Number:2018-000445-39
    Sponsor's Protocol Code Number:ACI-24-1801
    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:2018-07-04
    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 number2018-000445-39
    A.3Full title of the trial
    A Phase II Double-Blind, Randomized, Placebo-Controlled, Adaptive Design Study to Assess the Safety, Tolerability, Immunogenicity and Target Engagement of ACI-24 Formulations in Patients with Mild Alzheimer’s Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study comparing the safety and clinical effects of different formulations of a new vaccine, ACI-24 with placebo in patients with mild Alzheimer's disease
    A.4.1Sponsor's protocol code numberACI-24-1801
    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 SponsorAC Immune 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 supportAC Immune SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAC Immune SA
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressEPFL Innovation Park, Building B
    B.5.3.2Town/ cityLausanne
    B.5.3.3Post code1015
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41213459121
    B.5.5Fax number+41213459120
    B.5.6E-mailclinicaltrials@acimmune.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 nameACI-24
    D.3.2Product code ACI-24
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPal1-15 acetate salt
    D.3.9.2Current sponsor codePal1-15 acetate salt
    D.3.9.3Other descriptive namePAL 1-15
    D.3.9.4EV Substance CodeSUB192705
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number340 to 460
    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 No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alzheimer's Disease
    E.1.1.1Medical condition in easily understood language
    Alzheimer's Disease
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    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
    To assess the safety and tolerability of the ACI-24 formulations in patients with mild Alzheimer’s disease.
    To assess the effects of ACI-24 formulations on induction of anti-Aβ antibody responses in serum.
    To assess the effects of ACI-24 formulations on brain amyloid load in patients with mild Alzheimer’s disease, assessed by florbetaben-PET imaging at 52 weeks (12 months) and 76 weeks (18months).
    E.2.2Secondary objectives of the trial
    To explore the effects of ACI-24 formulations on putative biomarkers of the progression of Alzheimer’s disease including concentrations of total tau and phosphorylated tau protein (phosphotau) and Aβ (Aβ1-42 and Aβ1-40) in blood and/or CSF.
    To explore the effects of ACI-24 formulations on T cell activation in blood.
    To explore the effects of ACI-24 formulations on whole brain and hippocampal volume by volumetric MRI.
    To explore the effects of ACI-24 formulations on clinical and cognitive endpoints in patients with mild Alzheimer’s disease.
    To explore the influence of ACI-24 formulations on blood inflammatory cytokines.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Probable AD dementia according to NIA-AA core clinical criteria
    2. Florbetaben-PET scan at screening consistent with the presence of amyloid pathology
    3. Mini-Mental Status Examination (MMSE) 20-28 points
    4. Age greater than or equal to 50 and less than or equal to 85 years
    5. Patients receiving acetylcholinesterase inhibitor at a stable dose for at least 3 months prior to screening or patients not receiving acetylcholinesterase inhibitor treatment for at least 3 months prior to screening
    6. Patients cared for by a reliable spouse or caregiver to assure compliance, assist with clinical assessments and report safety issues, and spouse or caregiver consents to serve in this role.
    7. Women must be post-menopausal for at least one year, surgically sterilized or using reliable contraceptive measures. Male patients with partners of child bearing potential must be willing to use appropriate contraceptive measures (i.e. condoms) during the study
    8. Patients who in the opinion of the investigator are able to understand and provide written informed consent
    9. Patients and caregivers must be fluent in the official language(s) of the country they are living in and able to comply with all study procedures
    10. Patients are lucid, clear and oriented x4(awareness of person, knowledge of place, time/date and event)
    E.4Principal exclusion criteria
    1. Patients whose MRI scan (1.5 or 3T) at screening shows alternative pathology including severe vascular encephalopathy and/or more than 5 micro-hemorrhages.
    2. Patients who meet NINDS/AIREN criteria for vascular dementia
    3. Patients with other medical conditions which may influence cognitive performance e.g. Parkinson’s disease
    4. Patients with any unstable medical condition (e.g. uncontrolled epilepsy, uncontrolled hypertension) and/or history of chronic or recurrent infectious or inflammatory conditions which could hamper interpretation of safety
    5. Patients receiving memantine within 3 months prior to screening
    6. Patients with a history of hemorrhagic stroke
    7. Patients with a history of non-hemorrhagic stroke or myocardial infarction within the last year
    8. Patients with a history of major psychiatric disorder within the past 2 years including abuse of drug or alcohol
    9. Significant risk of suicide defined, using the Columbia-Suicide Severity Rating Scale, as the subject answering: “yes” to suicidal ideation questions 4 or 5 or answering: “yes” to suicidal behavior within the past 12 months
    10. Patients with a history of inflammatory neurological disorders including meningoencephalitis
    11. Patients with deviations from normal values for hematologic parameters, liver function tests, and other biochemical measures, that are judged to be clinically significant by the site investigator
    12. Patients with a history of autoimmune disease
    13. Patients with a history of cancer within the past 5 years other than treated squamous cell carcinoma, basal cell carcinoma and melanoma in situ, or in-situ prostate cancer or in-situ breast cancer which have been fully removed and are considered cured
    14. Patients who have received any vaccine within the past 2 weeks before screening
    15. Patients who have previously received AD immune therapeutic agents, except passive immunotherapy with the last dose received at least 6 months before screening or five half-lives whichever is longer
    16. Patients unable to undergo MRI and/or PET-scan examination for any reason, including metal implants contraindicated for MRI studies and claustrophobia; patients having contra-indication for CSF sampling
    17. Patients with a positive HIV and/or Hepatitis B or C test at screening
    18. Patients with positive syphilis serology
    19. Women who are pregnant or planning to become pregnant, or who are lactating
    20. Patients receiving any anticoagulant drug or anti-platelet therapy, except aspirin at doses of 100 mg daily or lower
    21. Patients with a history of sustained significant behavioral disturbances secondary to Alzheimer’s disease such as hallucinations, delusions, or agitation
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability: Adverse events; global assessment of tolerability; physical and neurological examination results; vital signs; suicidal ideation/behavior; MRI results; electrocardiogram; routine hematology and biochemistry evaluation in blood and urine; inflammatory markers in blood and CSF
    Biological Effect: Immune response titer (serum anti-Aβ antibody response)
    Target Engagement: Change from baseline of brain Aβ load as assessed with PET amyloid imaging
    E.5.1.1Timepoint(s) of evaluation of this end point
    Adverse events: all visits through 104 weeks of study duration
    Safety: selected visits through 104 weeks
    Tolerability: selected visits during 76 weeks of treatment period
    Biological Effect: all site visits through 104 weeks of study duration
    Efficacy/Target Engagement: at baseline, 52 and 76 weeks
    E.5.2Secondary end point(s)
    Biological Effects: Whole brain and hippocampal volume assessed by volumetric MRI, T-cell activation assessed by ELISPOT analysis, Inflammatory cytokines titer in blood, biomarkers in blood and/or CSF (e.g. total tau and phosphotau and Aβ levels), immune response in blood/CSF (e.g. anti-
    Aβ IgM titer in blood and anti-Aβ IgG titer in blood and optionally in CSF)
    Clinical Efficacy: Change from baseline of cognitive tests (COWAT, Trail Making Test parts A and B, Category Fluency Test, ADAS-cog 13 and MMSE), Global function [change from baseline in CDR-SB (Clinical Dementia Rating Scale-Sum of Boxes)], Activities of Daily Living (ADL) [change from baseline in (ADCS-ADL-MCI)]; behavior (change from baseline in NPI)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Biological Effects: selected visits during 104 weeks of study duration
    Clinical Efficacy: selected visits during 104 weeks of study duration
    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 Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 Yes
    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 years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 45
    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)
    open label study with a new formulation of ACI-24
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-15
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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