A Study to Evaluate Safety, Tolerability, and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease

Key Inclusion Criteria (Core Study) for Mild Cognitive Impairment due to Alzheimer's
Disease

- Intermediate likelihood:

1. Subjects who meet the National Institute of Aging - Alzheimer's Association (NIA-AA)
core clinical criteria for mild cognitive impairment due to Alzheimer's disease -
intermediate likelihood

2. Subjects who have a CDR score of 0.5 and a Memory Box score of 0.5 or greater at
Screening and Baseline

3. Subjects who report a history of subjective memory decline with gradual onset and slow
progression over the last one year before Screening; MUST be corroborated by an
informant

Key Inclusion Criteria (Core Study) for Mild Alzheimer's Disease Dementia:

1. Subjects who meet the NIA-AA core clinical criteria for probable Alzheimer's disease
dementia

2. Subjects who have a CDR score of 0.5-1.0 and a Memory Box score of 0.5 or greater at
Screening and Baseline

Inclusion Criteria (Core Study) that must be met by all subjects:

1. Subjects with 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 II (WMS-IV LMII):

1. Less than or equal to 15 for age 50 to 64 years

2. Less than or equal to 12 for age 65 to 69 years

3. Less than or equal to 11 for age 70 to 74 years

4. Less than or equal to 9 for age 75 to 79 years

5. Less than or equal to 7 for age 80 to 90 years

2. Positive amyloid load as indicated by PET or CSF assessment

1. PET assessment of imaging agent uptake into brain

2. CSF assessment of Aβ(1-42)

3. Age between 50 and 90 years, inclusive

4. Mini Mental State Examination (MMSE) score equal to or greater than 22, and equal to
or less than 30, at Screening and Baseline

5. Body Mass Index (BMI) greater than 17 and less than 35 at Screening or Baseline

6. Females must not be lactating or pregnant at Screening or Baseline (as documented by a
negative beta-human chorionic gonadotropin assay [ß-hCG]). A separate baseline
assessment is required if a negative screening pregnancy test was obtained more than
72 hours before the first dose of study drug.

7. Subjects on acetylcholinesterase inhibitor or memantine therapy or both for AD must be
on a stable dose for at least 12 weeks prior to Baseline. Treatment naive subjects can
be entered into the study. Unless otherwise stated, subjects must have been on stable
doses of all other permitted concomitant medications (ie, non-AD related) for at least
4 weeks prior to Baseline.

8. Subjects must have identified caregivers/informants

9. Subjects must provide written informed consent

Key Exclusion Criteria (Core study):

1. Any neurological condition that may be contributing to cognitive impairment above and
beyond that caused by the subject's AD

2. History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of
Screening

3. Any psychiatric diagnosis or symptoms, (e.g., hallucinations, major depression, or
delusions) that could interfere with study procedures in the subject

4. Geriatric Depression Scale (GDS) score ≥8 at Screening

5. Contraindications to MRI scanning, including cardiac pacemaker/ defibrillator,
ferromagnetic metal implants, e,g., in skull and cardiac devices other than those
approved as safe for use in MR scanners

6. Evidence of other clinically significant lesions that could indicate a dementia
diagnosis other than AD on brain MRI at Screening, or other significant pathological
findings on brain MRI at Screening

7. A prolonged QT/QTc interval (QTc greater than 450 ms) as demonstrated by a repeated
electrocardiogram (ECG)

8. Certain other specified medical conditions

9. Severe visual or hearing impairment that would prevent the subject from performing
psychometric tests accurately

Inclusion Criteria (Extension Phase):

1. Subjects who have completed Visit 42 (Week 79) of the Core Study or who discontinued
study drug during the Core Study due to any of the following reasons:

1. Alzheimer's Related Imaging Abnormality-Edema (ARIA-E)

2. Amyloid related imaging abnormality hemorrhage (ARIA-H) (superficial siderosis,
macrohemorrhage, or symptomatic microhemorrhage)

3. Prohibited or restricted medications that were prohibited during Core Study
conduct but are no longer prohibited in the Extension Phase

4. Subjects who were APOE4 positive and receiving treatment with BAN2401 10 mg/kg
biweekly

5. Any reason for discontinuation not related to prohibited medications, including
any AE that was considered not related to study drug, and that was not severe or
life-threatening

2. Must continue to have an identified caregiver or informant who is willing and able to
provide follow-up information on the subject throughout the course of the Extension
Phase

3. 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).

4. Must be able to physically attend clinic visits and be willing and able to comply with
all aspects of the protocol

Exclusion Criteria (Extension Phase):

1. Subjects who discontinued from the study drug or from the the Core Study for reasons
other than the following:

1. ARIA-E

2. ARIA-H (superficial siderosis, macrohemorrhage, or symptomatic microhemorrhage)

3. Prohibited or restricted medications that were prohibited during Core Study
conduct but are no longer prohibited in the Extension Phase

4. Subjects who were APOE4 positive and receiving treatment with BAN2401 10 mg/kg
biweekly

5. AE that was considered not related to study drug, and that was not severe or
life-threatening

2. Are currently abstinent, and do not agree to use a double-barrier method (as described
above) or refrain from becoming sexually active during the study period or for 28 days
after study drug discontinuation.

3. Severe visual or hearing impairment that would prevent the subject from performing
psychometric tests accurately.