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    The EU Clinical Trials Register currently displays   42564   clinical trials with a EudraCT protocol, of which   7007   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2018-004739-58
    Sponsor's Protocol Code Number:BAN2401-G000-301
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-04-17
    Trial results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2018-004739-58
    A.3Full title of the trial
    A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study With an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects With Early Alzheimer’s Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 clinical study to investigate the effects of BAN2401 in patients with Early Alzheimer's Disease
    A.4.1Sponsor's protocol code numberBAN2401-G000-301
    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 SponsorEisai Limited
    B.1.3.4CountryUnited Kingdom
    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 supportEisai Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEisai Limited
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressMosquito Way
    B.5.3.2Town/ cityHatfield
    B.5.3.3Post codeAL10 9SN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number4408456761400
    B.5.5Fax number44 08456761486
    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 nameBAN2401
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBAN2401
    D.3.9.1CAS number 1260393-98-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10 to 100
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    D. medicinal product typeMonoclonal Antibody
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease dementia
    E.1.1.1Medical condition in easily understood language
    Mild cognitive impairment or mild dementia caused by Alzheimer's disease which results in progressive memory loss, reasoning, language and other mental abilities.
    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 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 PT
    E.1.2Classification code 10074616
    E.1.2Term Prodromal 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 BAN2401 in subjects with early Alzheimer’s disease (EAD) by determining the superiority of BAN2401 compared with placebo on the change from baseline in the Clinical Dementia Rating–Sum of Boxes (CDR-SB) at 18 months of treatment.

    • To evaluate the long-term safety and tolerability of BAN2401 in subjects with EAD in the Extension Phase.
    • To evaluate whether the long-term effects of BAN2401 as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase
    E.2.2Secondary objectives of the trial
    Key Secondary Objective
    - Determine that BAN2401 is superior to placebo in reducing brain amyloid levels as measured by amyloid PET at 18 months of treatment in subjects with EAD
    - Evaluate the efficacy of BAN2401 in subjects with EAD by determining the superiority of BAN2401 compared with placebo on the change from baseline in the ADCOMS at 18 months of treatment
    - Evaluate the efficacy of BAN2401 in subjects with EAD by determining the superiority of BAN2401 compared with placebo on the change from baseline in the ADAS-cog14 at 18 months of treatment

    For all other objectives see protocol.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A longitudinal amyloid PET will be conducted at 3, 6, 12, and 18 months of treatment in a subgroup of consenting subjects imaging substudy) from any participating country to demonstrate target engagement and to assess amyloid clearance for BAN2401. Longitudinal CSF assessments will be collected at 12 and 18 months of treatment for soluble biomarker analysis (eg, Aβ[1-42], neurogranin, NFL, t-tau, and p-tau) in consenting subjects in any participating country to assess effects on indicators of disease pathology.

    See protocol for full details.
    E.3Principal inclusion criteria
    MCI due to AD–intermediate likelihood:
    1. Meet the NIA-AA core clinical criteria for MCI due to AD–intermediate likelihood.
    2. Have a global CDR score of 0.5 and a CDR Memory Box score of 0.5 or greater at Screening and Baseline.
    3. Report a history of subjective memory decline with gradual onset and slow progression over the last 1 year before Screening; must be
    corroborated by an informant.
    4. Meet the NIA-AA core clinical criteria for probable AD dementia.
    5. Have a global CDR score of 0.5 to 1.0 and a CDR Memory Box score of 0.5 or greater at Screening and Baseline.
    Key Inclusion Criteria that must be met by all subjects:
    6. Objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler Memory Scale IV-Logical Memory:
    a. ≤15 for age 50-64 years
    b. ≤12 for age 65-69 yrs
    c. ≤11 for age 70-74 yrs
    d. ≤9 for age 75-79 yrs
    e. ≤7 for age 80-90 yrs
    7. Positive biomarker for brain amyloid pathology as indicated by at least 1 of the following:
    a. PET assessment of imaging agent uptake into brain. Note: amyloid PET screens will be performed according to local regulatory guidelines and thus may be restricted for those subjects who are not suitable for lumbar puncture (LP) to obtain CSF for testing of eligibility.
    b. CSF assessment of t-tau/Aβ[1-42]
    NOTE1: Subjects who are on anticoagulant therapy may not participate in CSF assessments.
    NOTE2: Subjects may consent to both the PET and CSF assessments, but to confirm eligibility, a positive amyloid result is needed in only 1 of the 2 procedures (ie, the subject will be eligible even if 1 of the 2 results does not meet its eligibility criterion). Subjects who consent to amyloid PET or CSF at Screening for the purposes of eligibility are not required to participate in the amyloid PET, tau PET, or CSF longitudinal substudies. Use of a historical amyloid positive PET (conducted within 12 months before the planned date of randomization) is acceptable for determination of eligibility provided the subject did not participate in any clinical studies involving anti-amyloid therapies subsequent to the PET assessment. Historical PET will not suffice for the baseline assessment if the subject wishes to consent to the amyloid PET longitudinal substudy. The historical imaging data must be made available to the sponsor to confirm amyloid positivity.
    8. Male or female subjects aged ≥50 and ≤90 years, at the time of
    informed consent.
    9. MMSE score greater than or equal to 22 at Screening and Baseline and less than or equal to 30 at Screening and Baseline.
    10. Body mass index (BMI) greater than 17 and less than 35 at
    11. If receiving an approved AD treatment, such as AChEIs, or memantine, or both for AD, must be on a stable dose for at least 12
    weeks prior to Baseline. Treatment-naïve subjects for AD can be entered into the study. Unless otherwise stated, subjects must have been on stable doses of all other (ie, non-AD-related) permitted concomitant medications for at least 4 weeks prior to Baseline. Use of memantine will not be allowed for Japanese subjects.
    12. Have an identified study partner (defined as a person able to support the subject for the duration of the study and who spends at least 8 hours per week with the subject). The study partner must provide separate written informed consent. In addition, this person must be willing and able to provide follow-up information on the subject throughout the course of the study. This person must, in the opinion of the investigator, spend sufficient time with the subject on a regular basis such that the study partner can reliably fulfill the study requirements. A permanent study partner need not be living in the same residence with the subject.
    For such a study partner not residing with the subject, the investigator has to be satisfied that the subject can contact the study partner readily during the times when the study partner is not with the subject. If in doubt about whether a subject's care arrangements are suitable for inclusion, the investigator should discuss this with the medical monitor. Study partners need to participate in person for visits where clinical assessment of CDR (global and CDR-SB), EQ-5D-5L, QOL-AD, ADCS MCIADL and Zarit Burden Interview take place.
    13. Provide written informed consent. If a subject lacks capacity to
    consent in the investigator's opinion, the subject's assent should be
    obtained, if required in accordance with local laws, regulations and
    customs, plus the written informed consent of a legal representative
    should be obtained (capacity to consent and definition of legal
    representative should be determined in accordance with applicable local laws and regulations). In countries where local laws, regulations, and customs do not permit subjects who lack capacity to consent to participate in this study (eg Germany and Spain), they will not be enrolled.

    See protocol for full details.
    E.4Principal exclusion criteria
    1. Females who are breastfeeding or pregnant at Screening or Baseline
    2. Females of childbearing potential who:
    a. Within 28 days before study entry, did not use a highly effective
    method of contraception (see protocol for full details)
    b. Do not agree to use a highly effective method of contraception (as described in the protocol) throughout the entire study period and for 28 days after study drug discontinuation.
    3. Any neurological condition that may be contributing to cognitive
    impairment above and beyond that caused by the subject's AD.
    4. History of transient ischemic attacks, stroke, or seizures within 12
    months of Screening.
    5. Any psychiatric diagnosis or symptoms that could interfere with study procedures in the subject.
    6. GDS score greater than or equal to 8 at Screening.
    7. Contraindications to MRI scanning, including cardiac pacemaker/defibrillator, ferromagnetic metal implants.
    8. Evidence of other clinically significant lesions on brain MRI at
    Screening that could indicate a dementia diagnosis other than AD.
    9. Other significant pathological findings on brain MRI at Screening,
    including but not limited to: more than 4 microhemorrhages (defined as 10 mm or less at the greatest diameter); a single macrohemorrhage greater than 10 mm at greatest diameter; an area of superficial siderosis; evidence of vasogenic edema; evidence of cerebral contusion, encephalomalacia, aneurysms, vascular malformations, or infective lesions; evidence of multiple lacunar infarcts or stroke involving a major vascular territory, severe small vessel, or white matter disease; space occupying lesions; or brain tumors (however, lesions diagnosed as meningiomas or arachnoid cysts and less than 1 cm at their greatest diameter need not be exclusionary).
    10. Hypersensitivity to BAN2401 or any of the excipients, or to any
    monoclonal antibody treatment.
    11. Any immunological disease which is not adequately controlled, or which requires treatment with immunoglobulins, systemic monoclonal antibodies (or derivatives of monoclonal antibodies), systemic immunosuppressants, or plasmapheresis during the study.
    12. Subjects with a bleeding disorder that is not under adequate control (including a platelet count <50,000 or INR >1.5 for subjects who are not on anticoagulant treatment. Subjects who are on anticoagulant therapy should have their anticoagulant status optimized and be on a stable dose for 4 weeks before Screening.
    Subjects who are on anticoagulant therapy are not permitted to
    participate in CSF assessments.
    13. Have thyroid stimulating hormone (TSH) above normal range. Other tests of thyroid function with results outside the normal range should only be exclusionary if they are considered clinically significant by the investigator. This applies to all subjects whether or not they are taking thyroid supplements.
    14. Abnormally low serum vitamin B12 levels for the testing laboratory
    15. Known to be HIV positive.
    16. Any other clinically significant abnormalities in physical examination, vital signs, laboratory tests, or ECG at Screening or Baseline which in the opinion of the investigator require further investigation
    17. Subjects with malignant neoplasms within 3 years of Screening (see protocol for exceptions).
    18. Answer "yes" to C-SSRS suicidal ideation Type 4 or 5, or any suicidal behavior assessment within 6 months before Screening, at Screening, or at the Baseline Visit, or has been hospitalized or treated for suicidal behavior in the past 5 years before Screening.
    19. Known or suspected history of drug or alcohol abuse or dependence within 2 years before Screening or a positive urine drug test at Screening. Subjects who test positive for benzodiazepines or opioids in urine drug testing need not be excluded if in the clinical opinion of the investigator, this is due to the subject taking prior/concomitant medications containing benzodiazepines or opioids for a medical condition and not due to drug abuse.
    20. Any other medical conditions which are not stably and adequately controlled, or which in the opinion of the investigator(s) could affect the subject's safety or interfere with the study assessments.
    21. Subjects who are taking prohibited medications.
    22. Participation in a clinical study involving any therapeutic monoclonal antibody, protein derived from a monoclonal antibody, immunoglobulin therapy, or vaccine within 6 months before Screening (anti-amyloid therapies within 1 year before screening), unless it can be documented that the subject was randomized to placebo.
    23. Participation in a clinical study involving any anti-amyloid therapies (including any monoclonal antibody therapies and any BACE inhibitor therapies) unless it can be documented that the subject only received placebo.
    24. Subjects who have any known prior exposure to BAN2401.

    See protocol for full details.

    See protocol for full details
    E.5 End points
    E.5.1Primary end point(s)
    • Change from baseline in the CDR-SB at 18 months .

    • Safety assessments will be based on medical review of AE reports and the results of vital sign measurements, ECG, physical examinations, clinical laboratory tests, ADA test results, and any relevant test of cognitive function to evaluate decline. Additionally, MRI assessments of microhemorrhage, vasogenic edema, and other clinically significant abnormalities will be evaluated.
    • Change from core study baseline in CDR-SB
    E.5.1.1Timepoint(s) of evaluation of this end point
    • 18 months
    E.5.2Secondary end point(s)
    The key secondary endpoints for this study are:
    - Change from baseline in amyloid PET SUVR composite at 18 months for brain amyloid levels
    - Change from baseline in ADCOMS at 18 months
    - Change from baseline in ADAS-cog14 at 18 months

    The other secondary endpoints for this study are:
    - Rate of change over time (mean slope) based on CDR-SB score over 18 months
    - Correlation between changes in CDR-SB and changes in amyloid PET SUVR composite for brain amyloid levels
    - Time to worsening of global CDR scores at 18 months, eg, the worsening of global CDR score is defined as an increase from baseline by at least 0.5 points on the global CDR scale on 2 consecutive scheduled visits at which global CDR is undertaken
    - Change from baseline in MMSE at 18 months
    - Incidence of AEs and changes in vital signs, ECGs, laboratory safety tests, suicidality assessments, and MRI safety parameters
    - Population PK parameters of BAN2401 in serum, including but not limited, to AUC, Cav
    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 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. 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA46
    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
    Korea, Republic of
    Russian Federation
    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
    The end of the study will be when the last subject completes the last
    visit in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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: 310
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1256
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state84
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 307
    F.4.2.2In the whole clinical trial 1566
    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 who have completed Visit 42 (Week 79) have the option to participate in the Extension Phase. Those who choose not to participate in the Extension will complete the 3-month Follow-up Visits after their last dose of study drug in the study. Subjects who discontinue the study or study drug must comply with the Early Termination Visit (within 7 days after the last dose of study drug) and the Follow-up Visit (3 months after the last dose of study drug).
    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 Decision2019-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-19
    P. End of Trial
    P.End of Trial StatusOngoing
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