ELND005 in Patients With Mild to Moderate Alzheimer's Disease
- Registration Number
- NCT00568776
- Lead Sponsor
- OPKO Health, Inc.
- Brief Summary
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 (AD).
- Detailed Description
ELND005 (formerly known as AZD-103), scyllo-inositol, is being investigated as an orally administered treatment for AD. ELND005 may prevent or inhibit the build up of amyloid protein in the brains of AD patients.
This is a randomized, double-blind, placebo-controlled, dose-ranging, safety and efficacy study of oral ELND005 in male and female participants aged 50-85 years with mild to moderate AD. Approximately 340 patients will be enrolled into the study at approximately 65 study sites. Patients will be randomized to receive either ELND005 or placebo. Each patient's participation will last approximately 18 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 353
- Diagnosis of probable AD
- Age 50 to 85 years, inclusive
- Mini-Mental Status Exam (MMSE) score of 16-26, inclusive
- Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
- Fluency in English, French, or Spanish
- Stable doses of medications (cholinesterase inhibitors and memantine allowed)
- Caregiver is able to attend all study visits
- Significant neurological disease other than AD
- Major psychiatric disorder
- Significant medical illness
- History of stroke or seizure
- History of a heart attack within the last 2 years
- Prior treatment with certain experimental medicines
- Presence of pacemakers or foreign metal objects in the eyes, skin, or body that would prevent patient from having MRI scan
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Placebo Control - 2 ELND005 - 3 ELND005 - 4 ELND005 -
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS) Baseline and 78 weeks The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment.
Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Per Protocol Set; PPS) Baseline and 78 weeks The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment.
Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Full Analysis Set; FAS) Baseline and 78 weeks The ADCS-ADL is a 23-item scale that measures a subject's functional abilities as assessed by the subject's caregiver. This scale ranges from 0 to 78, with lower scores suggesting greater functional impairment.
Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Per Protocol Set; PPS) Baseline and 78 weeks The ADCS-ADL is a 23-item scale that measures a subject's functional abilities as assessed by the subject's caregiver. This scale ranges from 0 to 78, with lower scores suggesting greater functional impairment.
- Secondary Outcome Measures
Name Time Method Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Score From Baseline to Week 78 (Full Analysis Set; FAS) Baseline and 78 weeks The ADAS-Cog primarily measures cognitive ability. The version used in this study was comprised of 12 items with scores ranging from 0 to 75. Higher scores suggest greater cognitive impairment.
Change in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score From Baseline to Week 78 (Full Analysis Set; FAS) Baseline and 78 weeks The CDR-SB consists of 6 items; 3 measuring cognitive ability and 3 measuring functional ability. The score for each of the six items range from 0 to 3; hence the total score is between 0 and 18. Higher scores suggest greater cognitive impairment.
Change in Neuropsychiatric Inventory (NPI) Score From Baseline to Week 78 (Full Analysis Set; FAS) Baseline and 78 weeks The NPI is used to obtain information on the presence of severity of neuropsychological symptoms, and was specifically designed for use in Alzheimer's disease subjects. The scale consists of 12 items with each item having outcomes from 0 to 12; hence the total score ranges from 0 to 144. Higher scores suggest greater psychiatric impairment.
Trial Locations
- Locations (62)
Banner Alzheimer's Institute
🇺🇸Phoenix, Arizona, United States
Sun Health Research Institute
🇺🇸Sun City, Arizona, United States
University of Arizona, Health Sciences Center, Dept. of Neurology
🇺🇸Tucson, Arizona, United States
Margolin Brain Institute
🇺🇸Fresno, California, United States
Collaborative NeuroScience Network, Inc.
🇺🇸Garden Grove, California, United States
UCLA Alzheimer's Disease Center, Dept. of Neurology
🇺🇸Los Angeles, California, United States
UC Irvine Medical Center
🇺🇸Orange, California, United States
UCSF Medical Center, Dept. of Neurology
🇺🇸San Francisco, California, United States
Yale University School of Medicine, Alzheimer's Disease Research Unit
🇺🇸New Haven, Connecticut, United States
Georgetown University Medical Center, Dept. of Neurology
🇺🇸Washington, District of Columbia, United States
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