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    Summary
    EudraCT Number:2004-001187-52
    Sponsor's Protocol Code Number:AX.- CL – 06a
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-11-17
    Trial 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 ConcernedLatvia - SAM
    A.2EudraCT number2004-001187-52
    A.3Full title of the trial
    A Randomised, Double-Blind, Placebo-Controlled Trial
    to Evaluate the Safety and Efficacy of Two Different
    Dosages of Phenserine-tartrate in Patients with Mild to
    Moderate Probable Alzheimer’s Disease -
    Phenserine/APP and Aß
    A.4.1Sponsor's protocol code numberAX.- CL – 06a
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAxonyx Corporation
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsor
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 namePhenserine Tartrate
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codePT
    D.3.9.3Other descriptive namePhenserine Tartrate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10 to BID
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typenon competitive inhibitor of cholinesterase
    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 Information not present in EudraCT
    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 namePhenserine Tartrate
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codePT
    D.3.9.3Other descriptive namePhenserine Tartrate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15 to BID
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typenon competitive inhibitor of cholinesterase
    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
    Alzheimer’s Disease is a chronic progressive illness leading to loss of cognitive and intellectual abilities such as memory function, judgement and abstract thinking.
    In addition to the cognitive deficits the patients experience loss of their ability to take care of instrumental activities of daily living, they are not able to meet the most common requirements of daily life and so they are loosing their independence, needing intensive health care in final stages of the disease.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level Prim
    E.1.2Classification code 10001896
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate effects of Phenserine-tartrate on cognitive performance using a standardized psychometric test (Cognitive Performance - ADAS-cog) and to evaluate the drug effect on global function involving the caregiver (Global clinical impression of therapeutic effect- CIBIC+) in comparison with Placebo.
    E.2.2Secondary objectives of the trial
    Placebo controlled comparison of the efficacy of two different dosages of Phenserine-tartrate, 10mg BID and 15mg BID based on the following endpoints:
    - Activity of daily living - ADCS
    - Behavioural/psychiatric symptoms - NPI
    Effect on Amyloid production -blood plasma and Cerebrospinal fluid (=CSF) concentration of soluble APP, Aß1-40 and Aß1-42
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    • Signed informed consent by patient or the legally accepted representative prior to the
    initiation of any study specific procedures
    • Male or female patients of at least 50 years of age
    • Probable Alzheimer’s Disease consistent with NINCDS-ADRDA criteria (Appendix 1).
    • MRI or CT scan within the last 12 months prior to baseline; findings consistent with the
    diagnosis of probable Alzheimer’s Disease
    • Mini-Mental state examination score (MMSE) between 24 and 9 inclusive
    • Modified Hachinsky ischemic score equal or below 4
    • Female patients must be at least 2 years post-menopausal or surgically sterile
    • Caregiver available, if not living in the same household, caregiver sees patient at least 4 times a week
    • Patients living at home, old people’s home or an institutional setting without continuous
    nursing care
    • General health status acceptable for a participation in a 6 month clinical trial
    E.4Principal exclusion criteria
    • Violation of inclusion criteria not approved by clinical study director or study safety officer
    • Failure to perform or to evaluate screening or baseline examinations
    • Hospitalisation (except for study purposes or due to social reasons, e.g. hospitalisation to
    unburden the caregiver) or change of concomitant medication 4 weeks prior to screening
    or during screening period
    • Participation in another therapeutic clinical trial 3 months before baseline
    • Inability to swallow tablets

    Medical
    • Unsubstituted vitamin B12 or folate deficiency
    • Serum electrolytes (sodium, potassium, magnesium) out of normal range
    • Unsubstituted hypothyroidism with TSH > 6,00 µU/ml
    • Juvenile onset diabetes mellitus
    • Adult onset diabetes mellitus insufficiently controlled (HbA1c > 8 %)
    • Renal insufficiency with serum creatinine > 2mg/dl
    • Severe hypotension requiring treatment with more than 2 drugs
    • Lab values seriously abnormal, and/or more than 2 lab values abnormal not approved by
    clinical study director or study safety officer
    • Hypersensitivity to cholinergic drugs
    • Serious drug allergies
    • Malignant tumours within the last 5 years
    Cardiovascular
    • Myocardial infarction or unstable angina within the last 6 months before screening
    • History of more than 1 myocardial infarction during the last 5 years
    • Cardiomyopathy
    • Myocarditis
    • Atrial fibrillation
    • Severe hypotension requiring treatment with more than 2 drugs
    • Severe hypertension requiring treatment with more than 2 drugs
    • Bradycardia (frequency of heart beat < 50/min.)
    • Tachycardia (frequency of heart beat > 90/min.)
    • Presence of AV block (type II / Mobitz II and type III)
    • Congenital long QT syndrome
    • Sinus node dysfunction
    • Prolonged QTcB-interval (males > 450 and females > 470 msec)
    • QTcB dispersion > 100 msec
    • Presence of U wave
    Psychiatric
    • Episode of major depression in medical history
    • GDS score (15 item scale) > 5
    • History or presence of schizophrenia
    • Chronic intoxication or chronic substance use disorder with pharmaceuticals, drugs,
    alcohol or industrial poisons

    Neurological
    • Stroke within 6 months before screening or concomitant with onset of dementia
    • Tumours, subdural haematoma or other space occupying processes on CT/MRI
    • Head trauma with loss of consciousness within 1 year before or concurrent with onset of
    dementia
    • Onset of dementia within 1 year following cardiac arrest, surgery with general anaesthesia
    or resuscitation
    • Degenerative CNS disease, e.g. M. Huntington, Jacob-Creutzfeld disease, Downs
    syndrome
    • Wernickes encephalopathy
    • Acute or chronic CNS infection including tertiary syphilis
    Previous Medication
    • Acetylcholinesterase inhibitors 3 months before baseline
    • Any experimental drug 3 months before enrolment
    • Nootropics 1 month before screening
    • Promethazine, thioridazine, chlorprothixene, flunitrazepam or nitrazepam not discontinued
    2 weeks before screening
    • Antipsychotics if not given for sleep disturbances
    • Antidepressants, except stable treatment with SSRI´s for at least 3 months prior to
    screening
    Concomitant Medication
    • Peripherally acting drugs with effects on cholinergic transmission
    • Immunosuppresants
    • Antiparkinsonian therapy
    • Antiepileptics
    • Centrally active anti-hypertensive drugs like clonidine, alpha methyl dopa, guanidine,
    guanfacine or moxonidine
    • Non-steroidal anti-inflammatory drugs 72 h before blood plasma or CSF sampling
    • Cholesterol lowering drugs inhibiting HMG CoA reductase (simvastatin, pravastatin,
    fluvastatin, atorvastatin, cerivastatin)
    • Chronic intake of opioid containing analgesics
    • Sedating H1 antihistamines
    • Systemic cortico-steroids
    CSF sampling
    • Thrombocytopenia with platelet count < 140*103/µl
    • Coagulation disorders
    • Local skin or soft tissue infection along the needle tract
    • Papilledema during funduscopy
    • Evidence of high CSF pressure in CT/MRI
    E.5 End points
    E.5.1Primary end point(s)
    Placebo controlled comparison of the efficacy of two different dosages of Phenserine-tartrate, 10mg BID and 15mg BID based on the following endpoints:
    • Cognitive Performance - ADAS-cog+
    • Global clinical impression of therapeutic effect- CIBIC+
    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 Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.1Randomised Information not present in EudraCT
    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.8.3 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    150 patients will be recruited. Non-evaluable patients will be replaced until the specified total is archieved.
    Patients will receive Phenserine-tartrate 15mg BID, 10mg BID or placebo, according to a 2:2:1 randomisation in favour of the active treatment doses. The duration of the treatment for each patient will be 6 month.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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
    Either the patient should be able to give his consent personally or in case of more severe cases of Alzheimer's Disease the legally accepted representative will give the consent prior of any study specific procedures.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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)
    no specific treatment plan is foreseen. Patients will continue their normal treatment.
    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 Decision2004-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-10-13
    P. End of Trial
    P.End of Trial StatusCompleted
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