ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's Disease

This study has been completed.

First Received on June 29, 2009. Last Updated on July 13, 2011 History of Changes

Sponsor:	Elan Pharmaceuticals
Collaborator:	Transition Therapeutics
Information provided by:	Elan Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00934050

Purpose

The purpose of this study is to evaluate the long-term safety and tolerability of ELND005 beyond the 18 months of treatment in original randomized and blinded clinical trail ELND005-AD201.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: ELND005 (scyllo-inositol)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Long-Term Follow-Up Study of Oral ELND005 (AZD-103) in Subjects With 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 analyses will be based on the frequency and severity of adverse events and on clinically important changes in laboratory assessment results. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	June 2009
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ELND005	Drug: ELND005 (scyllo-inositol) Prior to 15Dec2009: ELND005 2000 mg PO BID for 48 weeks After 15Dec2009: ELND005 250 mg PO BID for 48 weeks Other Name: scyllo-inositol

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

This study is open only to subjects who have completed the week 78 visit in Study ELND005-AD201 while taking their assigned dose of study drug medication.

Exclusion Criteria:

Subject has no new medical contraindications to continued participation in the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934050

Show 38 Study Locations

Sponsors and Collaborators

Elan Pharmaceuticals

Transition Therapeutics

More Information

No publications provided

Responsible Party:	Jesse Cedarbaum, Elan Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00934050 History of Changes
Other Study ID Numbers:	ELND005-AD251
Study First Received:	June 29, 2009
Last Updated:	July 13, 2011
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 February 09, 2012