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    Summary
    EudraCT Number:2008-005260-14
    Sponsor's Protocol Code Number:ACI-91-0801
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-09-15
    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 ConcernedGermany - BfArM
    A.2EudraCT number2008-005260-14
    A.3Full title of the trial
    A double-blind placebo-controlled study of the safety, tolerability and efficacy of 12 months’ treatment with ACI-91 in patients with mild to moderate 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 effects of a compound ACI-91 with placebo in patients with mild to moderate Alzhiemer's disease
    A.4.1Sponsor's protocol code numberACI-91-0801
    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 supportPrivate Shareholders
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportPrivate Shareholders
    B.4.2CountryGermany
    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 Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressPSE Building B - EPFL
    B.5.3.2Town/ cityLausanne
    B.5.3.3Post code1015
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41216939142
    B.5.5Fax number+41216939120
    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-91
    D.3.2Product code ACI-91
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpirenzepine dihydrochloride monohydrate
    D.3.9.1CAS number 29868-97-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mild to moderate Alzheimer’s Disease
    E.1.1.1Medical condition in easily understood language
    Mild to moderate 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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    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 safety, tolerability including examination for potential negative effects on cognition of 12-month treatment with ACI-91 in patients with mild to moderate AD receiving a stable dose of an acetylcholinesterase inhibitor
    E.2.2Secondary objectives of the trial
    - To assess the biochemical effects of ACI-91 on biomarkers of Alzheimer’s disease including, amyloid β (Aβ1-42 and Aβ1-40), F2-isoprostanes, total tau and phosphotau, and BACE-1,
    - To explore the effects of ACI-91 on cognition, global function, activities of daily living and neuropsychiatric symptoms
    - To assess the plasma levels of ACI-91
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with a documented diagnosis of “probable Alzheimer’s Disease” according to NINDS-ADRDA criteria supported by the results of a brain MRI scan made within one year of screening
    - Patients with MMSE 18 – 26 at screening
    - Male and female patients of age 40-85 years
    - Patients cared for by a reliable caregiver either living-in or visiting on a daily basis to assure compliance, assist with clinical assessments to make sure that safety issues are reported
    - Women must be post-menopausal for at least one year, surgically sterilised or using reliable contraceptive measures, eg. oral contraceptive or double-barrier method
    - Patients who in the opinion of the investigator are likely to cooperate with the requirements of the study, able to hear, see and speak adequately to conduct the assessments and able to swallow the study medication
    - Patients receiving stable dose of acetylcholinesterase inhibitors for at least 4 months prior to screening.
    - Patients and caregivers must be fluent in German and able to comply with all study procedures
    - Patients giving written informed consent (ability to give consent).
    E.4Principal exclusion criteria
    - Clinically significant abnormalities of clinical haematology or biochemistry including, but not limited to, elevations greater than 1.5 times the upper limit of normal of SGOT, SGPT or creatinine
    - Patients with elevated prothrombin or partial thromboplastin time
    - Patients with a major depressive episode within the past 2 years or a history of recurrent major depression or a history of bipolar disorders according to DSM-IV criteria
    - Patients with a Hamilton Depression (17 Item) Scale total score of 14 or greater or an individual item score of 3 or greater on Depressed Mood, Feelings of Guilt or Suicide at screening.
    - Past or present history of abuse of drugs or alcohol
    - Patients with stroke or myocardial infarction within the past year
    - Participation in a trial of another investigational drug within the last three months prior to screening
    - Patients with other medical conditions which may influence cognitive performance e.g. Parkinson’s disease, normal pressure hydrocephalus, progressive supranuclear palsy brain tumor, recurrent seizures, subdural hematoma, multiple sclerosis, severe head injury with coma lasting for more than a day
    - Patients with an alternative cause for dementia as determined by MRI scan within 1 year prior to the study, at a time when the patient was known to be demented. Diffuse periventricular white matter changes need not result in exclusion.
    - Patients with vascular dementia according to NINDS-AIREN criteria
    - Patients with Vitamin B12 or folate deficiency or hypothyroidism unless on replacement therapy for at least three months.
    - Patients with a positive HIV and/or syphilis test at screening
    - Patients with closed angle glaucoma
    - Patients with symptomatic prostatic hypertrophy
    - Patients with any unstable medical condition which might alter the ability to complete the clinical study.
    - Patients with moderate or severe renal or hepatic impairment
    - Patients unable to undergo MRI examination for any reason, including claustrophobia
    - Patients who are lactating, pregnant or planning to be pregnant, or who have a positive pregnancy test at screening (women of childbearing potential)
    - Patients receiving anticoagulant drugs
    - Patients receiving anticholinergic drugs, eg oxybutinin, tolteridone, tricyclic antidepressants
    - Patients receiving neuroleptic drugs other than atypical antipsychotics
    - Patients receiving pirenzepine
    - Patients receiving antioxidants including Coenzyme Q10 or high dose vitamins (5 times the recommended dose of Vitamin E or Vitamin C)
    - Patients receiving MAO-A or MAO-B inhibitors eg selegiline, rasagiline
    - Patients receiving putative cognitive enhancers other than acetylcholinesterase inhibitors (eg ergoloid mesylates, nimodipine, piracetam, gingko biloba).
    - Patients receiving memantine currently or previously
    - Patients with a major psychiatric illness within the past 5 years
    - Patients who have been hospitalized involuntarily or at the request of the caregiver
    E.5 End points
    E.5.1Primary end point(s)
    Safety/tolerability:
    General: Adverse events, physical (including vital signs) and neurological examination, ECG, routine blood and urine analyses, global assessment of tolerability as well as cognitive assessment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoints Safety: 0, 4, 12, 24, 36, 52 and 56 weeks.
    E.5.2Secondary end point(s)
    Efficacy (Biochemical):
    - Plasma levels of Aβ1-42 and Aβ1-40
    - CSF levels of Aβ1-42 and Aβ1-40
    - CSF levels of F2-isoprostane
    - CSF levels of tau and phosphotau
    - CSF levels of BACE-1

    Efficacy (Clinical):
    - Change from baseline in cognition assessed by the MMSE, the Neuropsychological Test Battery (NTB) and Alzheimer's Disease Assessment Scale cognitive subpart (ADAS-cog)
    - Change from baseline in global function assessed by the Clinical Dementia Rating Scale (CDR) sum of boxes
    - Change from baseline in Activities of Daily Living (ADL) assessed by the Disability Assessment in Dementia Scale (DAD)
    - Change from baseline in neuropsychiatric symptoms assessed by the Neuropsychiatric Inventory Scale (NPI)

    Pharmacokinetics:
    - Plasma levels of ACI-91: sparse sampling at week 0, 12 and 52 in all subjects
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints Efficacy: 0, 12, 24, 36, 52 and 56 weeks.
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 concerned12
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months24
    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.1.1Number of subjects for this age range: 0
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    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 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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients suffering from Alzheimer's Disease
    F.4 Planned number of subjects to be included
    F.4.1In the member state56
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 64
    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)
    if a subject has ended his/her participation in the trial, the patient will be examined as per the final visit and appropriate early study completion CRFs will be completed wherever possible. No plans for treatment is foreseen.
    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 Decision2008-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-01-17
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