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: 

  • 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 


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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