ELND005 in Patients With Mild to Moderate Alzheimer's Disease - Tabular View

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ELND005 in Patients With Mild to Moderate Alzheimer's Disease

This study is ongoing, but not recruiting participants.

Study NCT00568776. Last updated on October 29, 2008. Information provided by Elan Pharmaceuticals

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	ELND005 in Patients With Mild to Moderate Alzheimer's Disease
Official Title ^†	A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Safety and Efficacy Study of Oral ELND005 (AZD-103) in Alzheimer's Disease
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.
Detailed Description	ELND005 (formerly known as AZD-103), scyllo-inositol, is being investigated as an orally administered treatment for Alzheimer's disease (AD). ELND005 may prevent or inhibit the build up of amyloid protein in the brains of Alzheimer's disease 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.
Study Phase	Phase II
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure ^†	Safety and Tolerability; Cognitive and Functional Measures [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Secondary Outcome Measure ^†
Condition ^†	Alzheimer Disease
Intervention ^†	Drug: ELND005 Drug: Placebo Control
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Active, not recruiting
Enrollment ^†	340
Start Date ^†	December 2007
Completion Date	May 2010
Eligibility Criteria ^†	Inclusion Criteria: Diagnosis of probable AD Age 50 to 85 years, inclusive Mini-Mental Status Exam 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
Gender	Both
Ages	50 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States, Canada

Administrative Information Fields
NCT ID ^†	NCT00568776
Organization ID	ELND005-AD201
Secondary IDs ^††
Study Sponsor ^†	Elan Pharmaceuticals
Collaborators ^††	Transition Therapeutics
Investigators ^†
Information Provided By	Elan Pharmaceuticals
Verification Date	October 2008
First Received Date ^†	December 4, 2007
Last Updated Date	October 29, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.