Authorised Therapeutic confirmatory (Phase III) Mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease dementia.

A Phase 3 clinical study to investigate the effects of BAN2401 in patients with Early Alzheimer's Disease.

EU CTIS ID: 2024-510887-22-00

What this study is testing

Core: - 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. Extension Phase: - 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.

Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

Diagnosis; MCI due to AD–intermediate likelihood: Meet NIA-AA core clinical criteria for MCI due to AD–intermediate likelihood.
Diagnosis; Key Inclusion Criteria that must be met by all subjects: BMI >17 and <35 at Screening.
Diagnosis; Key Inclusion Criteria that must be met by all subjects: 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.
Diagnosis; Key Inclusion Criteria that must be met by all subjects: 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.
Diagnosis; Key Inclusion Criteria that must be met by all subjects: 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.
Diagnosis; Key Inclusion Criteria that must be met by all subjects: Willing and able to comply with all aspects of the protocol.

You likely can't join if

Females who are breastfeeding or pregnant at screening or Baseline.
Hypersensitivity to BAN2401 or any of the excipients, or to any monoclonal antibody treatment.
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.
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.
Have 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.
Abnormally low serum vitamin B12 levels for the testing laboratory.

See the full eligibility criteria

Who can join

Diagnosis; MCI due to AD–intermediate likelihood: Meet NIA-AA core clinical criteria for MCI due to AD–intermediate likelihood.
Diagnosis; Key Inclusion Criteria that must be met by all subjects: BMI >17 and <35 at Screening.
Diagnosis; Key Inclusion Criteria that must be met by all subjects: 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.
Diagnosis; Key Inclusion Criteria that must be met by all subjects: 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.
Diagnosis; Key Inclusion Criteria that must be met by all subjects: 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.
Diagnosis; Key Inclusion Criteria that must be met by all subjects: Willing and able to comply with all aspects of the protocol.
Extension: See protocol for full details.
Diagnosis; MCI due to AD–intermediate likelihood: A global CDR score of 0.5 and a CDR Memory Box score of 0.5 or greater at Screening and Baseline.
Diagnosis; MCI due to AD–intermediate likelihood: 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.
Diagnosis; Mild AD dementia: Meet NIA-AA core clinical criteria for probable AD dementia.
Diagnosis; Mild AD dementia: 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.
Diagnosis; Key Inclusion Criteria that must be met by all subjects: Objective impairment in episodic memory as indicated by at least 1 SD below age-adjusted mean in the WMS-IV LMII, as follows a. ≤15 for age 50-64 years b. ≤12 for age 65-69 years c. ≤11 for age 70-74 years d. ≤9 for age 75-79 years e. ≤7 for age 80-90 years
Diagnosis; Key Inclusion Criteria that must be met by all subjects: 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 had not participated 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.
Diagnosis; Key Inclusion Criteria that must be met by all subjects: Male or female subjects aged ≥50, ≤90 years, at the time of informed consent.
Diagnosis; Key Inclusion Criteria that must be met by all subjects: MMSE score greater than or equal to 22 at Screening and Baseline and less than or equal to 30 at Screening and Baseline.

What rules you out

Females who are breastfeeding or pregnant at screening or Baseline.
Hypersensitivity to BAN2401 or any of the excipients, or to any monoclonal antibody treatment.
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.
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.
Have 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.
Abnormally low serum vitamin B12 levels for the testing laboratory.
Known to be HIV positive.
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.
Subjects with malignant neoplasms within 3 years of Screening.
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.
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.
Females of childbearing potential who: a. Within 28 days before study entry, did not use a highly effective method of contraception b. Do not agree to use a highly effective method of contraception throughout the entire study period and for 28 days after study drug discontinuation.
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.
Subjects who are taking prohibited medications.
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, unless it can be documented that the subject was randomized to placebo.
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.
Subjects who have any known prior exposure to BAN2401.
Subjects who were dosed in a clinical study involving any new chemical entities for AD within 6 months prior to Screening unless it can be documented that the subject was in a placebo treatment arm.
Participated in any other investigational medication or device study in the 8 weeks or 5 half-lives (whichever is longer) of the medication before randomization unless it can be documented that the subject was in a placebo treatment arm.
Planned surgery which requires general anesthesia that would take place during the study.
Severe visual or hearing impairment that would prevent the subject from performing psychometric tests accurately. Extension: See protocol for full details.
Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the subject's AD.
History of transient ischemic attacks, stroke, or seizures within 12 months of Screening.
Any psychiatric diagnosis or symptoms that could interfere with study procedures in the subject.
GDS score greater than or equal to 8 at Screening.
Contraindications to MRI scanning, including cardiac pacemaker/defibrillator, ferromagnetic metal implants.
Evidence of other clinically significant lesions on brain MRI at Screening that could indicate a dementia diagnosis other than AD.
Other significant pathological findings on brain MRI at Screening - see protocol for further details.

The study team makes the final eligibility decision.

Where it's taking place

Japan
Singapore
China
Russian Federation
Korea, Republic of
Canada
United Kingdom
United States
Australia

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Japan; Singapore; China; Russian Federation; Korea, Republic of; Canada and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.