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Research
Introduction
MAC Research
Autopsy Program
Healthy Volunteering
Investigator Requests
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A Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Oral ELND005 in Alzheimer's Disease
| Study Director |
Adam Boxer, MD, PhD |
| Sponsor |
Elan Pharmaceuticals, Inc. |
| Recruiting? |
No |
| Official Study Title |
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging,
Safety and Efficacy Study of Oral ELND005 (AZD-103) in Alzheimer’s Disease |
| Conditions Studied |
Mild-Moderate Alzheimer's disease |
| Intervention |
ELND005 is an oral agent which may inhibit aggregation of amyloid beta in
subjects with Alzheimer’s disease. |
| Purpose |
The purpose of this study is to evaluate the dose-related safety and efficacy
of multiple oral dosages of ELND005 as treatment for Alzheimer's disease. |
| Eligibility |
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| Inclusion Criteria |
Subjects must be between 50 and 85 years old, meet criteria for Alzheimer's
disease, and have a study partner who sees them at least 5 times a week be able to accompany them to all
study visits. Subjects may take Aricept, Exelon, Razadyne and/or Namenda but must be on stable doses of
these medications for 4 months. Subjects must be willing and able to have brain MRIs through the course
of the study. Subjects must also have an MMSE score between 16 and 26, inclusive, at time of screening. |
| Exclusion Criteria |
History of stroke or seizures, history of substance abuse or heart attack
within the last 2 years or most types of cancer within the last 5 years. Current treatment with
anticoagulant (blood thinners) medication, anti-seizure medication, or narcotic medications. Pacemakers,
shrapnel, or other metal implants in body also exclude subjects from participating. |
| What is Involved? |
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| Testing |
Neurological and physical examinations, MRIs, Chest X-ray, lumbar punctures
(optional), cognitive testing and neuropsychiatric assessments, EKGs, blood and urine specimen collection,
vital signs, genetic testing. |
| Frequency of Visits |
16 visits over 18 months. (~1 visit every 2-6 weeks) |
| Contact Information |
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| Coordinator |
Katie Adams |
| Phone |
(415) 476-0671 |
| Materials Needed Prior to Evaluation |
Diagnosis of probable Alzheimer's disease |
| Costs |
None. Parking will be validated for the Millberry Parking Garage at UCSF for
all study visits, and subjects will be reimbursed $25 per visit for meal and travel expenses. |
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