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    Summary
    EudraCT Number:2016-002005-19
    Sponsor's Protocol Code Number:TTP488-301
    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:2016-06-07
    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 number2016-002005-19
    A.3Full title of the trial
    RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, MULTI-CENTER REGISTRATION TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF TTP488 IN PATIENTS WITH MILD ALZHEIMER'S DISEASE RECEIVING ACETYLCHOLINESTERASE INHIBITORS AND/OR MEMANTINE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the Efficacy and Safety of Azeliragon (TTP488) in Patients with mild Alzheimer's Disease (STEADFAST)
    A.3.2Name or abbreviated title of the trial where available
    STEADFAST
    A.4.1Sponsor's protocol code numberTTP488-301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02080364
    A.5.4Other Identifiers
    Name:US IND Number:68, 445
    Name:CTA Control #Number:181266
    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 SponsorvTv THERAPEUTICS LLC
    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 supportvTv THERAPEUTICS LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationvTv THERAPEUTICS LLC
    B.5.2Functional name of contact pointGregory Wulff
    B.5.3 Address:
    B.5.3.1Street Address4170 MENDENHALL OAKS PKWY
    B.5.3.2Town/ cityHIGH POINT
    B.5.3.3Post codeNC 27265
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1336841 0300180
    B.5.5Fax number+1336841 0310
    B.5.6E-mailgwulff@vtvtherapeutics.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 nameAzeliragon
    D.3.2Product code TTP488
    D.3.4Pharmaceutical form Capsule, hard
    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 INNAzeliragon
    D.3.9.1CAS number 603148-36-3
    D.3.9.2Current sponsor codeTTP488
    D.3.9.3Other descriptive namePF-04494700, TTP-488
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboCapsule, hard
    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 ALZHEIMER'S DISEASE RECEIVING ACETYLCHOLINESTERASE INHIBITORS AND/OR MEMANTINE
    E.1.1.1Medical condition in easily understood language
    MILD ALZHEIMER'S DISEASE
    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 PT
    E.1.2Classification code 10012271
    E.1.2Term Dementia Alzheimer's type
    E.1.2System Organ Class 10029205 - Nervous system disorders
    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 10029205 - Nervous system disorders
    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 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10012268
    E.1.2Term Dementia (excl Alzheimer's type)
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10012296
    E.1.2Term Dementia of the Alzheimer's type, with depressed mood
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10012295
    E.1.2Term Dementia of the Alzheimer's type, with delusions
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10012294
    E.1.2Term Dementia of the Alzheimer's type, with delirium
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10012293
    E.1.2Term Dementia of the Alzheimer's type, uncomplicated
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10012292
    E.1.2Term Dementia of the Alzheimer's type NOS
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10066571
    E.1.2Term Progression of 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 evaluate the efficacy of azeliragon on cognitive [Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog)] and global function [Clinical Dementia Rating Scale Sum of Boxes (CDR-sb)] measures in patients with mild AD.
    E.2.2Secondary objectives of the trial
    Key Secondary
     To examine the effect of azeliragon on MRI volumetrics (e.g., whole brain volume, ventricular volume, hippocampal volume).
    * note: the decision as to the specific key secondary to support disease modification claim will be made prior to database lock.

    Secondary:
    Please refer to protocol for the full list
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally authorized representative) and caregiver/informant has been informed of all pertinent aspects of the study. Participants must be able to provide assent (where this is in accordance with local laws, regulations and ethics committee policy) and assent may be re-evaluated during the study at regular intervals.
    2. Participants and caregiver/informants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    3. The subject must have a reliable caregiver/informant with regular contact (i.e., 10 hours a week as combination of face-to-face visits and telephone contact acceptable) who will facilitate the subject’s full participation in the study. Caregivers/informant must have sufficient subject interaction to be able to provide meaningful input into the rating scales administered in this study where caregiver/informant input is required, in particular the CDR and evidence of this should be documented in source documentation. Participants who reside in assisted living facilities are permitted provided that they meet caregiver/informant criteria.
    4. Participants and caregiver/informants must be able to read, write, and speak the language in which psychometric tests are provided with visual and auditory acuity (corrected) sufficient to allow for accurate psychometric testing.
    5. Males and females (of non-childbearing potential) ages ≥50 years of age at screening.
    6. Diagnosis of probable AD, consistent with the criteria from the 2011 National Institute on Aging and the Alzheimer’s Association workgroup (McKhann et al., 2011). Evidence of progression needs to be documented in source documentation at the time of screening based on review of prior medical records and/or information gathered from the subject or caregiver/informant(s). Biomarker evidence of the pathophysiological process or neuronal injury associated with AD should be documented if data is available in participant’s medical records (not specifically measured for inclusion in this study).
    7. MRI consistent with a diagnosis of probable Alzheimer’s disease. A head CT scan may be used for evaluation if there is a documented contraindication to an MRI (e.g. pacemaker).
    8. Mini-Mental State Exam (MMSE) score of 21-26 inclusive at screening.
    9. CDR global score of 0.5 or 1 at screening.
    10. Rosen-Modified Hachinski Ischemia Score ≤4 at screening.
    11. Participants must be on a stable dose of a background cholinesterase inhibitor and/or memantine (approved by the relevant health authority where the trial is being conducted) at least 3 months prior to randomization and must agree not to change the dose during the study period unless the investigator judges that the dose needs to be reduced or stopped due to a safety and/or tolerability reason.
    12. No clinically significant, (in the opinion of the investigator) laboratory abnormalities at screening. If the results of clinical laboratory testing are outside normal reference ranges, the subject may be enrolled but only if these findings are determined to be not clinically significant by the investigator. This determination must be recorded in the subject’s source documents. A summary of values of potential clinical concern is provided in protocol appendix 1.
    13. Subject must be able to ingest oral medications.
    E.4Principal exclusion criteria
    1. Current evidence or history of neurological, psychiatric, and any other illness that could contribute to dementia including, but not limited to other neurodegenerative disorders (e.g., Lewy body disease, fronto-temporal dementia, vascular dementia), head injury with loss of consciousness proximate to the onset of dementia, participation in contact sports characterized by repeated head injuries, DSM-IV-TR criteria for any major psychiatric disorder including psychosis, current major depression, bipolar disorder, alcohol or substance abuse or dependence, neurosyphilis, vitamin B12 deficiency (see Exclusion 3, below), thyroid disease (unless adequately treated for at least 3 months with normalization of laboratory values) or any form of dementia other than AD.
    2. Participants from a family with known autosomal dominant AD associated with mutations in APP, PS1 or PS2 genes or strongly suspected, but not yet identified mutations in APP, PS1 or PS2 genes, or Down’s syndrome. Individuals from families with any number of late onset AD affected family members may participate in this study.
    3. Vitamin B12 levels lower than laboratory reported normal limits (and remains below on repeat testing). Participants may be enrolled following the initiation of B12 therapy for 4 weeks prior to dosing and confirmed within normal limits upon repeat.
    4. Diagnosis or history of cerebrovascular stroke, severe carotid stenosis, cerebral hemorrhage, intracranial tumor, subarachnoid hemorrhage that, as determined by the investigator, could either contribute to the patient’s current cognitive or functional status, impair his/her ability to fully participate in the trial or that may impact his/her status during an 18-month trial.
    5. Specific exclusionary brain MRI findings (as identified on the central MRI read) as determined by the investigator that could either significantly contribute to the patient’s current cognitive or functional decline, impair his/her ability to fully participate in the trial or that may impact his/her status during 18-month course of the trial. In any case, 10 or more microhemorrhages as identified by the central reading, is exclusionary. Grade three deep white matter changes (diffuse involvement of entire region) on the central reading report is exclusionary. If a head CT is used for assessment of eligibility, structural abnormalities as determined by the investigator that could either significantly contribute to the patient’s current cognitive or functional decline, impair his/her ability to fully participate in the trial or that may impact his/her status during 18-month course of the trial would be exclusionary.
    6. A current primary diagnosis of major psychiatric disorder, e.g., schizophrenia, bipolar disorder, major depressive disorder, or other severe psychiatric illness per the DSM-IV-TR criteria per the investigator’s judgment.
    7. Serious suicide risk
    8. History of cancer within the last 5 years except adequately treated cervical carcinoma in-situ, cutaneous basal cell or squamous cell cancer, or non-progressive prostate cancer not requiring treatment.
    9. Current (e.g., within the last 3 months) body mass index (BMI) of greater than or equal to 35 kg/m2 or a current (e.g., within the last 3 months) weight less than 45 kg.
    10. Any clinically significant hepatic or renal disease, elevated transaminase levels of greater than 1.5 times the upper limit of normal (ULN), creatinine greater than 1.5 x ULN.
    Patients with unstable, uncontrolled diabetes (HbA1c > 7.7%) and those requiring insulin.
    12. Participants with poorly controlled hypertension with or without existing therapy (systolic≥160 or diastolic≥100). Subjects will be allowed to participate with management of blood pressure below the exclusionary levels with introduction of an allowable medication and the subject has been on the drug for 4 weeks prior to baseline.
    13. Participants with evidence or history of severe drug allergies or allergy to any constituents of the study drug as formulated.
    14. Known history of alcohol or drug abuse or dependence within 5 years prior to dosing or a positive result on the drug screening test.
    15. Patients with pulmonary hypertension are excluded.
    16. Any contraindications to the MRI procedure based on local operating procedures and instructions . It is acceptable to premedicate patients per usual local practice provided this medication is not administered within 5 half-lives preceding any efficacy assessments. Patients with contraindications to MRI (ex: pacemakers) may undergo computed tomography (CT) on approval by Sponsor.
    17. Any contraindications to the FDG-PET study in the mild AD dementia subject cohort undergoing a PET scan.

    For full list of exclusion criteria, please refer to study protocol
    E.5 End points
    E.5.1Primary end point(s)
    Co-primary Endpoints:
    - Change from Baseline in the ADAS-cog at Month 18.
    - Change from Baseline in the CDR-sb at Month 18.

    E.5.1.1Timepoint(s) of evaluation of this end point
    18 months
    E.5.2Secondary end point(s)
    Key Secondary Endpoints:
    - Change from Baseline in brain volumetrics (e.g., whole brain volume, ventricular volume, hippocampal volume) at Month 18.

    Other Secondary Endpoints:
    - Please refer to the study protocol
    E.5.2.1Timepoint(s) of evaluation of this end point
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 concerned13
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Ireland
    New Zealand
    South Africa
    United Kingdom
    United States
    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 years2
    E.8.9.1In the Member State concerned months4
    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 months9
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 720
    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
    A suitable legal representative will be sought who will be provided with the information and they have the opportunity to ask questions they wish to, after which they will be asked to sign and date the informed consent form on behalf of the patient.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 800
    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)
    When the study stops, the participant's regular doctor will discuss with the participant the best way to treat their
    Alzheimer’s disease. There will be the option to receive the study drug in an open-label extension study, following the
    completion of the treatment period of this study by the participant, provided that they meet the eligibility criteria for the extension study.
    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 Decision2016-08-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-19
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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