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    Summary
    EudraCT Number:2019-000370-27
    Sponsor's Protocol Code Number:COR388-010-UK
    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:2019-05-09
    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 ConcernedUK - MHRA
    A.2EudraCT number2019-000370-27
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo Controlled Study of COR388 HCl in Subjects with Alzheimer’s Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of COR388 in Subjects with Alzheimer’s Disease
    A.4.1Sponsor's protocol code numberCOR388-010-UK
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03823404
    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 SponsorCortexyme, Inc.
    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 supportCortexyme, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWorldwide Clinical Trials
    B.5.2Functional name of contact pointMedical Affairs
    B.5.3 Address:
    B.5.3.1Street Address1st Floor Waterfron House, Beeston Business Park
    B.5.3.2Town/ cityBeeston
    B.5.3.3Post codeNG9 1LA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44(0)115 956 7711
    B.5.5Fax number+44(0)115 922 0960
    B.5.6E-mailannette.janus@worldwide.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 nameCOR388 HCl 80 mg
    D.3.2Product code COR388
    D.3.4Pharmaceutical form Capsule
    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 INNCOR388 HCl
    D.3.9.2Current sponsor codeCOR388
    D.3.9.3Other descriptive nameCOR388
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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.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 nameCOR388 HCl 40 mg
    D.3.2Product code COR388
    D.3.4Pharmaceutical form Capsule
    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 INNCOR388 HCl
    D.3.9.2Current sponsor codeCOR388
    D.3.9.3Other descriptive nameCOR388
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    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
    E.1.1.1Medical condition in easily understood language
    Alzheimer’s Disease
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Psychological processes [F02]
    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
    Assess the efficacy of 2 dose levels of COR388 HCl in Alzheimer’s disease (AD) subjects;
    Assess the safety and tolerability of 2 dose levels of COR388 HCl in AD subjects
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    •Cerebrospinal fluid sub-study (subjects who agree to have LP):
    - CSF Aβ42, total Tau, and phosphorylated Tau;
    - Bacterial DNA in the CSF on quantitative polymerase chain reaction (qPCR); and
    - CSF inflammatory markers.
    •Magnetic resonance imaging sub-study (subjects who have MRIs done in conjunction with the study):
    - Hippocampal volume; and
    - Cortical thickness.
    •Clinical periodontitis sub-study (subjects enrolled at selected sites):
    - Pocket Depth (PD);
    - Clinical Attachment Level (CAL) at 6 sites per tooth (distobuccal [DB], buccal, mesiobuccal [MB], distolingual [DL], lingual [L], and mesiolingual [ML]);
    - The percentage of sites with Bleeding on Probing (BOP); and
    - Biomarkers of P. gingivalis infection and inflammation in subgingival plaque (SGP) and buccal cell swabs.
    E.3Principal inclusion criteria
    1.Subject has provided full written informed consent prior to the performance of any protocol-specified procedure; or if unable to provide informed consent due to cognitive status, subject has provided assent and a legally authorized representative has provided full written informed consent on behalf of the subject.
    2.Caregiver has provided full written informed consent, on a separate informed consent form (ICF), on his/her own behalf prior to the performance of any protocol-specified procedure.
    3.Male and female subjects must be 55 years to 80 years of age, at the time of consent.
    4.Subject has probable AD dementia according to the NIA-AA criteria (McKhann 2011) with clinical evidence of progressive cognitive decline in the last year. Clinical decline will be determined based on serial cognitive test scores, if available, or subject/caregiver report as documented by the Investigator.
    5.Subject has an MMSE score between 12 and 24 inclusive at both screening and Visit 2 and a ≤3-point difference between these visits.
    6.Subject has a Modified Hachinski score ≤4 at screening.
    7.Subject has brain MRI scan consistent with the diagnosis of AD performed during the screening period. Computed Tomography scan can be used only if the subject has an absolute contraindication for MRI.
    8.Subject has a primary caregiver willing to accept responsibility for supervising the treatment (e.g., administering study drug), accompanying the study subject to clinic visits and assessing the condition of the subject throughout the study in accordance with all protocol requirements.
    9.Subject is not likely to experience a change in living conditions (e.g., institutionalization, moving to a different city, etc.), or change in primary caregiver, during participation in the trial.
    10.Subjects with background symptomatic therapy with acetylcholinesterase inhibitors, and/or memantine, are allowed as long as the dose has been stable for 90 days prior to screening and no changes are planned during the study.
    11.Subjects who have occasional use of sedative agents are acceptable, but these agents should not be given within 48 hours prior to cognitive assessments.
    12.Subjects who have background medications used for stable chronic illnesses that are not prohibited by the protocol are allowed. The dose of psychoactive drugs must be stable for 30 days prior to screening, and no changes must be planned during the study unless for safety reasons.
    13.Subject has body mass index <38 kg/m2 at Screening.
    14.Subject must be able to ingest oral medications and can swallow the study drug without breaking or crushing.
    15.Subject must be willing to undergo Apolipoprotein E genotype (ApoE) genetic testing (ApoE results may be disclosed after trial completion).
    16.Subjects participating in the study must meet one of the following criteria:
    a.Females: Surgically sterilized (e.g., hysterectomy, bilateral oophorectomy or tubal ligation) for at least 6 months or postmenopausal (postmenopausal females must have no menstrual bleeding for at least 1 year). If not postmenopausal, agree to use a highly effective method of contraception that can achieve a failure rate of less than 1% per year when used consistently and correctly, such as hormonal contraception or a double barrier method (e.g., intrauterine device plus condom or true abstinence defined as in line with the preferred and usual lifestyle of the subject. Periodic abstinence e.g. calendar, ovulation, symptothermal, post-ovulation methods are not acceptable. Declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception) from 30 days prior to dosing until 30 days after last dose and have negative human chorionic gonadotropin (β hCG) test for pregnancy at screening.
    b.Males who have not had a vasectomy must use appropriate contraception methods (barrier or true abstinence defined as in line with the preferred and usual lifestyle of the subject. Periodic abstinence e.g. calendar, ovulation, symptothermal, post-ovulation methods are not acceptable. Declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception) from 30 days prior to dosing until 90 days after last dose.
    E.4Principal exclusion criteria
    1.Subject has imaging consistent with other differential dementia diagnoses other than the diagnosis of AD
    2.Subject has had an increase or restoration of cognition based on medical history
    3.Subjects who meet the following imaging exclusion criteria will not be included in this study:
    a.Claustrophobia that will result in significant anxiety and difficulty lying still for MRI or CT scan
    b.Severe motor problems or chronic pain indication that prevents the subject from lying still for brain imaging
    4.Subject with history of cancer requiring systemic therapy in the last 5 years; except for localized cancer of the skin and in-situ cervical cancer successfully treated with surgical excision. Stable (for at least 90 days) prostate cancer is allowed
    5.Subject has a contraindication for LP, such as infected skin over the needle entry site, possible increased intracranial pressure, severe thrombocytopenia or coagulopathy, suspected spinal epidural abscess, or spinal structural abnormalities that would interfere with LP procedures
    6.Subject has evidence of clinically significant unstable cardiovascular, pulmonary, renal, hepatic, gastrointestinal, neurologic or metabolic disease within 6 months prior to Screening
    7.Subject has any of the following cardiovascular conditions:
    a.Unstable angina, uncompensated and/or symptomatic congestive heart failure (Grade 2 or higher on the NYHA scale) or myocardial infarction within 6 months
    b.Acute or poorly controlled blood pressure >180 mmHg systolic or >100 mmHg diastolic
    c.Current, or recent history of, any of the following that are clinically significant in the investigator's judgment: arrhythmia, hypotension, heart block, any bundle branch block, ventricular pacing, symptomatic ectopy, unstable arrhythmias including atrial fibrillation; stable atrial fibrillation is allowed
    d.History of prolonged QT or prolonged QT on screening ECG (QTcF > or = 480 msec)
    e.History of prolonged PR interval or prolonged PR interval on screening ECG (PR >210 msec)
    f.History of prolonged QRS interval or prolonged QRS interval on screening ECG (QRS >120 msec)
    g.Supraventricular or ventricular ectopy on the screening ECG or Brugada pattern on ECG
    8.Subject with major stroke, uncontrolled seizure disorder, or other medical illnesses that in the Investigator's opinion will increase the subject's risk of participation in the study or confound study assessments
    9.Subject with history or current evidence of major neurological or psychiatric illness such as schizophrenia, bipolar disorder, Parkinson's, etc. Subjects with major depressive disorder that may interfere with the patient's ability to perform the study and all assessments
    10.Subject with history of violent or aggressive behavior that requires medication to control
    11.Subjects with active suicidal thoughts in the 6 months preceding screening or at baseline; or have a history of a suicide attempt in the previous 2 years, or more than 1 lifetime suicide attempt; or are at serious suicide risk in the Investigator's clinical judgment
    12.Subject with history of alcohol or drug use disorder within 12 months of screening as defined by the Diagnostic and Statistical Manual of Mental Disorders-5
    13.Subject with previous treatment with investigational vaccine therapy for AD
    14.Subject has participated in another Investigational New Drug (IND) research study involving small molecule drugs within 60 days or biological drugs within 90 days prior to the first dose of study drug or 5 half-lives of the investigational drug, whichever is longer
    15.Subject has a history of epilepsy or seizure disorder requiring ongoing treatment, or any seizure or loss of consciousness within 6 months prior to enrollment
    16.Subject has any of the following laboratory findings at screening:
    a.Alanine aminotransferase >3 x upper limit of normal (ULN), aspartate aminotransferase >3 x ULN, or history of clinically significant liver disease in the Investigator's judgment
    b.Hemoglobin < or = 10 g/dl
    c.INR >1.5 or total bilirubin >1.5 x ULN (unless subject has evidence of Gilbert's disease)
    d.Creatinine clearance (CL) of <45 ml/min
    e.Poorly controlled diabetes, defined by hemoglobin A1C (HbA1C) >8.
    f.Positive blood screen for HIV 1 and 2, HBsAg, or HCV-Ab at Screening
    g.Positive urine screen for drugs of abuse that include opiates, cocaine, amphetamines, or barbiturates
    17.Subject has abnormal laboratory tests that suggest an alternate etiology for dementia. In these cases, the patient should be re-evaluated to determine if these potential causes of dementia have been addressed. Only if these causes have been ruled out as the cause of the dementia can the patient be enrolled
    18.Use of systemic (i.e., oral, intravenous, etc., but not topical) antibiotics in the last 60 days or history of recurrent infection that requires chronic or repeated courses of antibiotics
    E.5 End points
    E.5.1Primary end point(s)
    The two co-primary endopints are:
    - Mean change in Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) from baseline to the end of treatment period.
    - Mean change in Alzheimer’s Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL) from baseline to the end of treatment period
    E.5.1.1Timepoint(s) of evaluation of this end point
    54 weeks
    E.5.2Secondary end point(s)
    • Change in Clinical Dementia Rating-Sum of Boxes (CDR-SB)
    • Change in Mini-Mental State Examination (MMSE)
    • Change in Neuropsychiatric Inventory (NPI)
    E.5.2.1Timepoint(s) of evaluation of this end point
    54 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) 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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    France
    Netherlands
    Poland
    Spain
    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 years2
    E.8.9.2In all countries concerned by the trial months4
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 423
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients with Alzheimer’s Disease
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state59
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 573
    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)
    None
    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 Decision2019-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-24
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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