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

Tracking Information
First Received Date ^ICMJE	December 4, 2007
Last Updated Date	July 9, 2009
Start Date ^ICMJE	December 2007
Estimated Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 6, 2007)	Safety and Tolerability; Cognitive and Functional Measures [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: December 4, 2007)	Safety and Tolerability; Cognitive and Functional Measures [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT00568776 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	ELND005 in Patients With Mild to Moderate Alzheimer's Disease
Official Title ^ICMJE	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 ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Alzheimer Disease
Intervention ^ICMJE	Drug: ELND005 Drug: Placebo Control
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	340
Estimated Completion Date	May 2010
Estimated Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT ID ^ICMJE	NCT00568776
Responsible Party	VP Clinical Development, Elan Pharmaceuticals
Study ID Numbers ^ICMJE	ELND005-AD201
Study Sponsor ^ICMJE	Elan Pharmaceuticals
Collaborators ^ICMJE	Transition Therapeutics
Investigators ^ICMJE
Information Provided By	Elan Pharmaceuticals
Verification Date	July 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP