MCI and PRODROMAL DEMENTIA STUDY (MMSE: 24 - 30)
Protocol:
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.
Study Duration:
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Subject participating in the placebo controlled period only will be approximately 102 weeks
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For subjects who enter the optional open label, the total duration will be approximately 206 weeks
Inclusion Criteria:
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.
Exclusion Criteria:
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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