ELND005 in Patients With Mild to Moderate Alzheimer's Disease

NCT00568776 | Completed Phase 2 Results DMC

• 1 other identifier: ELND005-AD201
• Study Type: interventional
• Target: 353
• Locations: 2 countries
• Sites: 62

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 (AD).

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (4)

• Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS)

  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.

  Baseline and 78 weeks

• Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Per Protocol Set; PPS)

  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.

  Baseline and 78 weeks

• Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Full Analysis Set; FAS)

  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.

  Baseline and 78 weeks

• 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)

  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.

  Baseline and 78 weeks

Secondary Outcomes (3)

• Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Score From Baseline to Week 78 (Full Analysis Set; FAS)

  Baseline and 78 weeks

• Change in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score From Baseline to Week 78 (Full Analysis Set; FAS)

  Baseline and 78 weeks

• Change in Neuropsychiatric Inventory (NPI) Score From Baseline to Week 78 (Full Analysis Set; FAS)

  Baseline and 78 weeks

Study Arms (4)

1

PLACEBO COMPARATOR

Drug: Placebo Control

2

ACTIVE COMPARATOR

Drug: ELND005

3

ACTIVE COMPARATOR

Drug: ELND005

4

ACTIVE COMPARATOR

Drug: ELND005

Interventions

Placebo Control DRUG

ELND005 matched placebo capsules for oral administration, bid for 78 weeks

Also known as: scyllo-inositol

1

ELND005 DRUG

ELND005 capsules for oral administration at a dose of 2000 mg bid for 78 weeks

4

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OPKO Health, Inc.: lead

Study Sites (62)

Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States

Location

Sun Health Research Institute

Sun City, Arizona, 85351, United States

Location

University of Arizona, Health Sciences Center, Dept. of Neurology

Tucson, Arizona, 85724, United States

Location

Margolin Brain Institute

Fresno, California, 93720, United States

Location

Collaborative NeuroScience Network, Inc.

Garden Grove, California, 92845, United States

Location

UCLA Alzheimer's Disease Center, Dept. of Neurology

Los Angeles, California, 90095, United States

Location

UC Irvine Medical Center

Orange, California, 92868, United States

Location

UCSF Medical Center, Dept. of Neurology

San Francisco, California, 94143, United States

Location

Yale University School of Medicine, Alzheimer's Disease Research Unit

New Haven, Connecticut, 06510, United States

Location

Georgetown University Medical Center, Dept. of Neurology

Washington D.C., District of Columbia, 20057, United States

Location

Brain Matters Research, Inc.

Delray Beach, Florida, 33445, United States

Location

Sunrise Clinical Research, Inc

Hollywood, Florida, 33021, United States

Location

Miami Jewish Home and Hospital For The Aged

Miami, Florida, 33137, United States

Location

Avision Research Associates, LLC

Miami, Florida, 33173, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

Roskamp Institute

Sarasota, Florida, 34243, United States

Location

Neurology Clinical Research, Inc.

Sunrise, Florida, 33351, United States

Location

University of South Florida Suncoast Alzheimer's and Gerontology Center

Tampa, Florida, 33617, United States

Location

Premiere Research Institute

West Palm Beach, Florida, 33407, United States

Location

Emory University, Dept. of Neurology

Atlanta, Georgia, 30329, United States

Location

Dekalb Neurology Associates, LLC

Decatur, Georgia, 30033, United States

Location

Department of Neurology - Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Medical Center, Department of Neurology

Kansas City, Kansas, 66160, United States

Location

Innovative Clinical Concepts

Paducah, Kentucky, 42003, United States

Location

Brigham and Women's Hospital, Dept. of Neurology

Boston, Massachusetts, 02115, United States

Location

University of Michigan, Taubman Health Care Center, Dept. of Neurology

Ann Arbor, Michigan, 48109, United States

Location

University of Nevada School of Medicine

Las Vegas, Nevada, 89102, United States

Location

Comprehensive Clinical Research

Berlin, New Jersey, 08009, United States

Location

The Memory Enhancement Center of America, Inc.

Eatontown, New Jersey, 07724, United States

Location

Global Medical Institutes

Princeton, New Jersey, 08540, United States

Location

Albuquerque Neuroscience, Inc.

Albuquerque, New Mexico, 87109, United States

Location

Upstate Clinical Research, LLC

Albany, New York, 12205, United States

Location

Neurological Associates of Albany, PC

Albany, New York, 12208, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Columbia University Sergievsky Center

New York, New York, 10032, United States

Location

AD-CARE, Monroe Community Hospital

Rochester, New York, 14620, United States

Location

Raleigh Neurology Associates

Raleigh, North Carolina, 27607, United States

Location

Neurology & Neuroscience Center of Ohio

Toledo, Ohio, 43623, United States

Location

Medford Neurological and Spine Clinic

Medford, Oregon, 97504, United States

Location

Summit Research Newtwork, Inc.

Portland, Oregon, 97210, United States

Location

Abington Neurological Associates, Inc.

Abington, Pennsylvania, 19001, United States

Location

The Clinical Trial Center, LLC

Jenkintown, Pennsylvania, 19046, United States

Location

University of Pittsburgh Alzheimer Disease Research Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Butler Hospital, Memory and Aging Center

Providence, Rhode Island, 02906, United States

Location

Alliance for Neuro Research, LLC dba Absher Neurology, PA

Greenville, South Carolina, 29615, United States

Location

Radiant Research San Antonio

San Antonio, Texas, 78229, United States

Location

University of Utah, Dept. of Neurology

Salt Lake City, Utah, 84108, United States

Location

Clinical Neuroscience Research Associates, Inc-The Memory Clinic

Bennington, Vermont, 05201, United States

Location

University of Vermont Medical Center, Fletcher Allen Health Care, Dept. of Neurology

Burlington, Vermont, 05405, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22903, United States

Location

Glenrose Rehabilitation Hospital

Edmonton, Alberta, T5G 0B7, Canada

Location

University of British Columbia Hospital, Division of Neurology

Vancouver, British Columbia, V6T 2B5, Canada

Location

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2, Canada

Location

Saint Joseph's Health Care London, Saint Joseph's Hospital, Dept. of Cognitive Neurology

London, Ontario, N6A 4V2, Canada

Location

Parkwood Hospital

London, Ontario, N6C 5J1, Canada

Location

Sisters of Charity of Ottawa Health Service

Ottawa, Ontario, K1N 5C8, Canada

Location

Kawartha Regional Memory Clinic

Peterborough, Ontario, K9H 2P4, Canada

Location

Toronto Memory Program

Toronto, Ontario, M3B 2S7, Canada

Location

Whitby Mental Health Memory Clinic

Toronto, Ontario, M5T 2S8, Canada

Location

Gerontion Research, Inc.

Toronto, Ontario, M6M 3Z5, Canada

Location

Neuro-Rive-Sud Memory Clinic

Greenfield Park, Quebec, J4V 2J2, Canada

Location

Recherche Clinique de Neurologie (Hospital Maisonneuve Rosemont)

Montreal, Quebec, H1T 2M4, Canada

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

scyllitol

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

The two high dose groups of ELND005 were discontinued before study end, so the efficacy analysis was based only on placebo and ELND005 250 mg bid groups.

Results Point of Contact

• Title: Aleksandra pastrak, MD, PhD, Vice President, Clinical Development
• Organization: Transition Therapeutics Ireland Limited

apastrak@transitiontherapeutics.com

+1 416 263 1227

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2007
• First Posted: December 6, 2007
• Study Start: December 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: November 1, 2019
• Results First Posted: March 29, 2012

Record last verified: 2019-10

Locations

CA (12); US (50)