A Placebo-Controlled Double-blind Parallel-group 18 Month Study To Confirm Safety and Efficacy of BAN2401 in Subjects With Early Alzheimer s Disease

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Alzheimer's Disease
  • Age: Between 50 - 90 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    MCI due to AD–intermediate likelihood:
    1. Subjects who meet the National Institute of Aging–Alzheimer’s Association (NIA-AA) core clinical criteria for MCI due to AD–intermediate likelihood.
    2. Subjects who 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.
    Mild AD dementia:
    1. Subjects who meet the NIA-AA core clinical criteria for probable AD dementia
    2. Subjects who 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.
    All subjects:
    1. Subjects who have objective impairment in episodic memory
    2. Subjects with positive biomarker for brain amyloid pathology
    3. MMSE score greater than or equal to 22 at Screening and Baseline and less than or equal to 30 at Screening and Baseline.
    4. Body mass index (BMI) greater than 17 and less than 35 at Screening.
    5. Have an identified study partner
    6. Provide written informed consent.
    7. Willing and able to comply with all aspects of the protocol.

You may not be eligible for this study if the following are true:

    1. Female subjects who are pregnant or breastfeeding
    2. Female subjects who did not use highly effective contraceptives within 28 days before study entry
    3. Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the subject’s AD.
    4. Subjects with history of transient ischemic attacks (TIA), stroke, or seizures within 12 months of Screening.
    5. Subjects with any psychiatric diagnosis or symptoms
    6. Geriatric Depression Scale (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. Subjects with hypersensitivity to BAN2401
    10. Subjects with a bleeding disorder that is not under adequate control
    11. Subject who have thyroid stimulating hormone above normal range.
    12. Subjects with known to be human immunodeficiency virus (HIV) positive
    13. Subjects who are taking prohibited medications.
    14. Subjects who have any known prior exposure to BAN2401.

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