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:
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Conditions: Alzheimer's Disease
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Age: Between 50 years - 90 years
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Gender: Male or Female
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Other Inclusion Criteria:
MCI due to AD–intermediate likelihood:- Subjects who meet the National Institute of Aging–Alzheimer’s Association (NIA-AA) core clinical criteria for MCI due to AD–intermediate likelihood.
- 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.
- 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.
- Subjects who meet the NIA-AA core clinical criteria for probable AD dementia
- 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.
- Subjects who have objective impairment in episodic memory
- Subjects with positive biomarker for brain amyloid pathology
- MMSE score greater than or equal to 22 at Screening and Baseline and less than or equal to 30 at Screening and Baseline.
- Body mass index (BMI) greater than 17 and less than 35 at Screening.
- Have an identified study partner
- Provide written informed consent.
- Willing and able to comply with all aspects of the protocol.
You may not be eligible for this study if the following are true:
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- Female subjects who are pregnant or breastfeeding
- Female subjects who did not use highly effective contraceptives within 28 days before study entry
- Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the subject’s AD.
- Subjects with history of transient ischemic attacks (TIA), stroke, or seizures within 12 months of Screening.
- Subjects with any psychiatric diagnosis or symptoms
- Geriatric Depression Scale (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.
- Subjects with hypersensitivity to BAN2401
- Subjects with a bleeding disorder that is not under adequate control
- Subject who have thyroid stimulating hormone above normal range.
- Subjects with known to be human immunodeficiency virus (HIV) positive
- Subjects who are taking prohibited medications.
- Subjects who have any known prior exposure to BAN2401.
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.