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 (AD).

Condition	Intervention	Phase
Alzheimer Disease	Drug: Placebo Control Drug: ELND005	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized 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:

Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS) [ Time Frame: Baseline and 78 weeks ] [ Designated as safety issue: No ]
The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment.
Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Per Protocol Set; PPS) [ Time Frame: Baseline and 78 weeks ] [ Designated as safety issue: No ]
The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment.
Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Full Analysis Set; FAS) [ Time Frame: Baseline and 78 weeks ] [ Designated as safety issue: No ]
The ADCS-ADL is a 23-item scale that measures a subject's functional abilities as assessed by the subject's caregiver. This scale ranges from 0 to 78, with lower scores suggesting greater functional impairment.
Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Per Protocol Set; PPS) [ Time Frame: Baseline and 78 weeks ] [ Designated as safety issue: No ]
The ADCS-ADL is a 23-item scale that measures a subject's functional abilities as assessed by the subject's caregiver. This scale ranges from 0 to 78, with lower scores suggesting greater functional impairment.

Secondary Outcome Measures:

Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Score From Baseline to Week 78 (Full Analysis Set; FAS) [ Time Frame: Baseline and 78 weeks ] [ Designated as safety issue: No ]
The ADAS-Cog primarily measures cognitive ability. The version used in this study was comprised of 12 items with scores ranging from 0 to 75. Higher scores suggest greater cognitive impairment.
Change in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score From Baseline to Week 78 (Full Analysis Set; FAS) [ Time Frame: Baseline and 78 weeks ] [ Designated as safety issue: No ]
The CDR-SB consists of 6 items; 3 measuring cognitive ability and 3 measuring functional ability. The score for each of the six items range from 0 to 3; hence the total score is between 0 and 18. Higher scores suggest greater cognitive impairment.
Change in Neuropsychiatric Inventory (NPI) Score From Baseline to Week 78 (Full Analysis Set; FAS) [ Time Frame: Baseline and 78 weeks ] [ Designated as safety issue: No ]
The NPI is used to obtain information on the presence of severity of neuropsychological symptoms, and was specifically designed for use in Alzheimer's disease subjects. The scale consists of 12 items with each item having outcomes from 0 to 12; hence the total score ranges from 0 to 144. Higher scores suggest greater psychiatric impairment.

Enrollment:	353
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
Placebo Comparator: 1	Drug: Placebo Control ELND005 matched placebo capsules for oral administration, bid for 78 weeks Other Name: scyllo-inositol
Active Comparator: 2	Drug: ELND005 ELND005 capsules for oral administration at a dose of 250 mg bid for 78 weeks Other Name: scyllo-inositol
Active Comparator: 3	Drug: ELND005 ELND005 capsules for oral administration at a dose of 1000 mg bid for 78 weeks Other Name: scyllo-inositol
Active Comparator: 4	Drug: ELND005 ELND005 capsules for oral administration at a dose of 2000 mg bid for 78 weeks

Detailed Description:

ELND005 (formerly known as AZD-103), scyllo-inositol, is being investigated as an orally administered treatment for AD. ELND005 may prevent or inhibit the build up of amyloid protein in the brains of AD 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 (MMSE) 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
ClinicalTrials.gov Identifier:	NCT00568776 History of Changes
Other Study ID Numbers:	ELND005-AD201
Study First Received:	December 4, 2007
Results First Received:	September 27, 2011
Last Updated:	March 1, 2012
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 May 16, 2013