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

Sponsor:	Elan Pharmaceuticals
Collaborator:	Transition Therapeutics
Information provided by:	Elan Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00568776

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.

Condition	Intervention	Phase
Alzheimer Disease	Drug: ELND005 Drug: Placebo Control	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Safety and Efficacy Study of Oral ELND005 (AZD-103) in Alzheimer's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Inositol

U.S. FDA Resources

Further study details as provided by Elan Pharmaceuticals:

Primary Outcome Measures:

Safety and Tolerability; Cognitive and Functional Measures [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	340
Study Start Date:	December 2007
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: ELND005
2: Active Comparator	Drug: ELND005
3: Active Comparator	Drug: ELND005
4: Placebo Comparator	Drug: Placebo Control

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.

Eligibility

Ages Eligible for Study:	50 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568776

Show 62 Study Locations

Sponsors and Collaborators

Elan Pharmaceuticals

Transition Therapeutics

More Information

No publications provided

Responsible Party:	Elan Pharmaceuticals ( VP Clinical Development )
ClinicalTrials.gov Identifier:	NCT00568776 History of Changes
Other Study ID Numbers:	ELND005-AD201
Study First Received:	December 4, 2007
Last Updated:	August 11, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders

Mental Disorders
Inositol
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 02, 2010