MCI and PRODROMAL DEMENTIA STUDY (MMSE: 24 - 30)
Evaluate the Efficacy and Safety of IV drug XXX infusion once a month in Subjects with Early Alzheimer's Disease. IV drug is a human monoclonal antibody that recognizes aggregated forms of β-amyloid (Aβ), including soluble Aβ oligomers and deposited fibrillary Aβ.
Subject participating in the placebo controlled period only will be approximately 102 weeks
For subjects who enter the optional open label, the total duration will be approximately 206 weeks
1. Aged 50 to 85 years old
2. MMSE 24-30
3. Must have at least 6 years of education or work experience.
4. Must meet criteria for MCI due to Alzheimer's Disease or mild Alzheimer's Disease.
5. Subject has a study partner who is willing to attend study related visits at least once in 4 months.
1. Any uncontrolled medical or neurological/neurodegenerative condition other than Alzheimer's Disease (e.g., substance abuse, vitamin B12 deficiency, abnormal thyroid function, stroke or other cerebrovascular condition, lewy body dementia, fronto-temporal dementia, head trauma).
2. Clinically significant psychiatric illness (e.g., uncontrolled major depression, schizophrenia, bipolar affective disorder) within 6 months prior to Screening.
3. TIA or stroke or any unexplained loss of consciousness within 1 year prior to Screening.
4. History of bleeding disorder.
5. Poorly controlled diabetes mellitus, (HbA1c) value of ≥ 7%.
6. History of unstable angina, myocardial infarction, chronic heart failure, unstable atrial fibrillation within 1 year prior to Screening.
7. Uncontrolled hypertension.
8. History of malignancy or carcinoma. Subjects with cancers in remission for more than 5 years prior to Screening are not excluded.
9. History of seizure within 10 years.
10. Indication of impaired liver function, AST/ ALT ≥ 2 x the upper limit of normal.
11. History or evidence of an autoimmune disorder requiring chronic use of systemic corticosteroids or other immunosuppressants.
12. Recent history (within 1 year of Screening) of alcohol or substance abuse.
13. History of or positive test result HIV, Hepatitis C or B
14. Use of allowed chronic medications at doses that have not been stable for at least 4 weeks prior to Screening Visit 1 or use of Alzheimer's Disease medications (including donepezil, rivastigmine, galantamine, tacrine, and memantine) at doses that have not been stable for at least 8 weeks prior to Screening.
15. Use of medications with platelet anti-aggregant or anti-coagulant properties (the use of aspirin at a prophylactic dose ≤ 325 mg daily] is allowed).
16. Use of illicit narcotic medication.
17. Contraindications to having a brain MRI (e.g., pacemaker)
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