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    Summary
    EudraCT Number:2009-010922-21
    Sponsor's Protocol Code Number:B2571007(3134K1-2203-EU)
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-06-12
    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 - PEI
    A.2EudraCT number2009-010922-21
    A.3Full title of the trial
    A phase II a , Multicenter, Randomized , Third -party Unblinded , Long- term Extension study to Determine Safety, Tolerability and Immunogenicity of ACC-001 with QS-21 Adjuvant in Subjects with Mild to Moderate Alzheimer's Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study in patients suffering of Alzheimer disease in order to learn whether a new compound (ACC-001 with an adjuvant) is safe, acts like a vaccine and has an effect on patient mental performance.
    A.4.1Sponsor's protocol code numberB2571007(3134K1-2203-EU)
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00955409
    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 SponsorWyeth Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc, 500 Arcola Road, Collegeville, PA 19426 USA
    B.1.3.4CountryUnited States
    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 supportWyeth Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc, 500 Arcola Road, Collegeville, PA 19426 USA
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18007181021
    B.5.5Fax number+18007391119
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.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 nameACC-001
    D.3.2Product code ACC-001
    D.3.4Pharmaceutical form Solution 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.3.9.2Current sponsor codeACC-001 (PF-05236806)
    D.3.9.3Other descriptive nameA-Beta-1-7-CRM197 Conjugate
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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.IMP: 2
    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 nameACC-001
    D.3.2Product code ACC-001
    D.3.4Pharmaceutical form Solution 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.3.9.2Current sponsor codeACC-001
    D.3.9.3Other descriptive nameA-Beta-1-7-CRM197 Conjugate
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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.IMP: 3
    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 nameSTIMULON
    D.3.2Product code QS-21
    D.3.4Pharmaceutical form Solution 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 INNSTIMULON
    D.3.9.1CAS number 141256-04-04
    D.3.9.2Current sponsor codeQS-21
    D.3.9.3Other descriptive nameSTIMULON
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with mild to moderate Alzheimer's disease.
    E.1.1.1Medical condition in easily understood language
    Patients with Alzheimer disease living at home or community dwelling expected to attend all study visits with a study partner able to visit him/her approximately 5 times per week
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10012271
    E.1.2Term Dementia Alzheimer's type
    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
    The primary objective of the study is to evaluate the long-term safety and tolerability of doses of 3, 10, and 30 µg of ACC-001 (CRM-conjugated A-beta [1-7] antigen in combination with QS-21 adjuvant) in subjects with mild to moderate AD.
    E.2.2Secondary objectives of the trial
    No secondary objectives in study only Exploratory objectives:
    • To assess the immunogenicity of doses of 3, 10, and 30 µg of ACC-001 in combination with QS-21.
    • To assess the long-term efficacy of ACC-001 in subjects with mild to moderate AD.
    • To evaluate the effect of ACC-001 on patient quality of life (QoL) and caregiver dependence and related health outcomes.
    • To compare the efficacy at the end of the study between those subjects who received ACC-001 with or without QS-21 in the preceding double-blind trial and those subjects who received phosphate-buffered saline (PBS) or QS-21 in the preceding trial.
    • To evaluate the change from baseline volumes for whole brain volume, brain boundary shift integral (BBSI), ventricular volume, hippocampal boundary shift integral (HBSI) and ventricular boundary shift integral (BSI) as assessed from MRI scans.
    • To evaluate the change from baseline of A-beta, total tau, and phosphorylated tau (p-tau) in cerebrospinal fluid at week 78.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects were randomized under previous 3134K1-200-EU study and met all inclusion and none of the exclusion criteria.
    2. Subject must have completed through week 78 of study 3134K1-200-EU and received at least 3 doses of investigational product and has been compliant in the opinion of the investigator and sponsor.
    3. Screening brain MRI scan is consistent with the diagnosis of AD.
    4. Mini-Mental State Examination (MMSE) score >=10.
    5. Lives at home with appropriate caregiver capable of accompanying the subject on all clinic visits, or community dwelling with caregiver capable of accompanying the subject on all clinic visits and visiting with the subject approximately 5 times per week for the duration of the study.
    6. In the opinion of the investigator, the subject and the caregiver will be compliant and have a high probability of completing the study.
    7. The subject and caregiver are likely to be able to participate in all scheduled examinations and complete all required tests.
    E.4Principal exclusion criteria
    1. Significant neurological disease other than AD that may affect cognition or function.
    2. Early termination (ET) from the preceding 3134K1 200-EU study.
    3. Experienced a SAE in the preceding double-blind study deemed related to investigational product.
    4. Brain MRI evidence of vasogenic edema (VE) during the preceding 3134K1 200-EU study.
    5. History of screening visit brain MRI scan indicative of any other significant abnormality including but not limited to more than 4 microhemorrhages (<10 mm), evidence of a single prior hemorrhage > 1 cm3, multiple lacunar infarcts (2 or more) or evidence of a single prior infarct > 1 cm3, evidence of a cerebral contusion, encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or spaceoccupying lesions (eg, arachnoid cysts or brain tumors, such as meningioma).
    6. Current clinically important systemic illness that is likely to result in deterioration of the subject’s condition or affect the subject’s safety during the study.
    7. Current presence of a clinically significant major psychiatric disorder (e.g., Major Depressive Disorder) according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders,Fourth Edition-Text Revision (DSM-IV-TR), or symptom (e.g.,hallucinations, suicidal ideation, suicidal behavior), that could affect the subject's ability to complete the study.
    8. Other clinically significant abnormality on screening visit which includes physical, neurological, laboratory, or electrocardiogram (ECG) examination (eg, atrial fibrillation) that could compromise the study or be detrimental to the subject.
    9. Current use of clopidogrel (Plavix) and central nervous system (CNS) stimulants eg, methylphenidate [Ritalin]).
    10. Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, cerebrospinal fluid (CSF) shunts, or metal fragments or foreign objects in the eyes, skin, or body, or claustrophobia that would contraindicate a brain MRI scan.
    E.5 End points
    E.5.1Primary end point(s)
    Safety assessments will include vital sign measurements, weight, physical and neurological examinations, 12-lead ECG recordings, and brain MRI scans (at screening and before each immunization and at the end of the study), including T2*/gradient echo MRI). Clinical laboratory evaluations will include complete blood count (CBC) with platelet count, chemistry panel, and urinalysis, thyroid panel, serum vitamin B12 and folate, coagulation studies, and circulating immune complexes and anti-A-beta titers.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At every study visit
    E.5.2Secondary end point(s)
    No secondary endpoints in study - exporataory endpoints are:
    To assess the immunogenicity of doses of 3, 10, and 30 ug of ACC-001 (CRM-conjugated A-beta [1-7] antigen in combination with QS-21 adjuvant) in subjects with mild to moderate AD. Change from baseline levels of anti-A-beta IgG at week 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104. baseline is defined as level prior to first treatment with ACC-001 with QS 21. Anti-A-beta IgM and IgG subclass antibody levels may be assessed at selected time points.
     To assess the long-term efficacy of ACC-001 in subjects with mild to moderate AD utilizing Alzheimer disease assessment scale-cognitive (ADAS-Cog), mini-mental state examination (MMSE), neuropsychiatric test battery (NTB), disability assessment for dementia (DAD), neuropsychiatric inventory (NPI), and clinical dementia rating-sum of boxes (CDR-SOB) at week 0, 26, 52, 78, and 104.
     To evaluate the health outcomes of times spent caregiving and resource utilization (Resource Use Dementia [RUD-lite]), quality of life in patients with AD [QoL-AD], and Dependence Scale (DS) at week 0, 26, 52, 78, and 104 To compare the efficacy at the end of the study between those subjects who received ACC-001in the preceding double-blind trial and those subjects who received placebo (phosphate-buffered saline [PBS] or QS-21) in the preceding trial.
     To evaluate the change from baseline volumes for whole brain volume, brain boundary shift integral (BBSI), hippocampal boundary shift integral (HBSI), ventricular volume, and ventricular boundary shift integral (VBSI) as assessed from MRI scans, at month 24 –(week 104).
     To evaluate the change from baseline of A-beta, total tau, and phosphorylated tau (p-tau) in cerebrospinal fluid at week 78.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At various timepoint between Day 1 and Week 104
    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 No
    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 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 Yes
    E.8.2.3.1Comparator description
    ACC-001 + adjuvant (QS-21)
    E.8.2.4Number of treatment arms in the trial3
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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 Information not present in EudraCT
    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
    Last visit of the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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: 34
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 52
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Alzheimer's disease patients may need a legal representative signature.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state36
    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)
    Subjects can maintain basic therapy with cholinesterase inhibitors and/or memantine throughout their participation in the trial. The standard of care therapy at the study site will be provided after the patient's participation has ended.
    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 Decision2009-09-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-08-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-12-17
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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