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

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

Genetics Home Reference related topics:

Alzheimer disease

MedlinePlus related topics:

Alzheimer's Disease

ChemIDplus related topics:

Inositol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Safety and Efficacy Study of Oral ELND005 (AZD-103) in Alzheimer's Disease

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
Estimated Study Completion Date:	May 2010
Estimated 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

Contacts


Contact: Study Coordinator	1-877-687-8839

Show 62 Study Locations

Sponsors and Collaborators

Elan Pharmaceuticals

Transition Therapeutics

More Information

Responsible Party:	Elan Pharmaceuticals ( Jesse Cedarbaum )
Study ID Numbers:	ELND005-AD201
First Received:	December 4, 2007
Last Updated:	August 11, 2008
ClinicalTrials.gov Identifier:	NCT00568776
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders

Mental Disorders

Inositol

Alzheimer Disease

Central Nervous System Diseases

Neurodegenerative Diseases

Brain Diseases

Dementia

Cognition Disorders

Delirium

Additional relevant MeSH terms:

Vitamin B Complex

Growth Substances

Vitamins

Physiological Effects of Drugs

Nervous System Diseases

Micronutrients

Tauopathies

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008

Sponsors and Collaborators:	Elan Pharmaceuticals Transition Therapeutics
Information provided by:	Elan Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00568776