ELND005 in Patients With Mild to Moderate Alzheimer's Disease
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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).
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
353 participants in 4 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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