Status:
TERMINATED
Phase II Study of Intravenous Immunoglobulin (IVIg) for Alzheimer's Disease
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Baxter BioScience
National Institutes of Health (NIH)
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
The overall goal of this double-blind Phase II study is to evaluate the safety, efficacy and biological mechanisms of action of Intravenous Immunoglobulin (IVIg) in the treatment of mild to moderate s...
Detailed Description
Abnormal processing of the beta-amyloid protein is thought to be an early and causative event in the pathogenesis of Alzheimer's disease (AD). Immunotherapy targeting beta amyloid (Aβ) has demonstrate...
Eligibility Criteria
Inclusion
- Diagnosis of probable Alzheimer's disease (AD) of mild to moderate severity (as determined by a Mini Mental State Examination (MMSE) score of 14 - 26 inclusive).
- Ability to give informed consent, designate a decision-maker or have an already recognized decision-maker (such as a legal guardian or health care proxy).
- Ability to comply with testing and infusion regimen.
- An able caregiver willing to participate (such as a spouse, child, other relative, close friend, aide or other professional caregiver closely involved in helping the patient take care of himself/herself).
- Venous access suitable for repeated infusion and phlebotomy.
- On stable doses of approved AD medications for at least 3 months.
- As applicable, on stable doses of psychoactive medications (e.g. antidepressants, antipsychotics) for at least 6 weeks.
- Neuroimaging performed after symptom onset consistent with the patient's diagnosis.
- Clinical laboratory values within normal limits or if abnormal, judged clinically insignificant by the Principal Investigator.
- Women who want to take part in this study must either be post-menopausal, surgically sterilized or agree to avoid becoming pregnant during the entire period of their participation in this study.
Exclusion
- Non-Alzheimer dementia.
- Active renal disease.
- Abnormally high serum viscosity levels.
- Immunoglobulin A (IgA) deficiency.
- Untreated congestive heart failure, unstable angina or a history of recent myocardial infarction.
- Unstable arrhythmia.
- Untreated or poorly controlled hypercholesterolemia.
- Untreated or poorly controlled hypertension.
- Poorly controlled diabetes.
- Thrombosis (central or peripheral) in the past year.
- Modified Hachinski score \> 5.
- Active cancer diagnosis, except basal cell carcinoma.
- Active autoimmune or neuroimmunologic disorder.
- History of IVIg treatment in past 6 months.
- Untreated major depression or other major psychiatric disorders.
- Known coagulopathy or platelet counts \< 100,000.
- Positive serology for Hepatitis B or C, or HIV.
- Active migraines or frequent headaches (3 or more times per week).
- Taking immunosuppressive drugs.
- Chronic (more than thrice weekly) use of non-steroidal anti-inflammatory drugs (NSAIDs), excluding aspirin 81 milligrams daily.
- Received an investigational treatment for AD within 3 months of study entry.
- A history of or current disorder or disease that in a physician co-investigator's judgment may impede the subject's participation in the study, pose immoderate risk to the patient or confound the results of the study
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00299988
Start Date
February 1 2006
End Date
April 1 2010
Last Update
December 11 2019
Active Locations (1)
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1
Weill Medical College of Cornell University
New York, New York, United States, 10021