Back to resultsELND005 Long-Term Follow-up Study in Subjects With Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ELND005 (scyllo-inositol)
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility 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.
Sites / Locations
- Banner Alzheimer's Institute
- Sun Health Research Institute
- University of Arizona, Health Sciences Center, Dept. of Neurology
- Margolin Brain Institute
- Collaborative NeuroScience Network, Inc.
- Yale University School of Medicine, Alzheimer's Disease Research Unit
- Brain Matters Research
- Sunrise Clinical Research, Inc
- Roskamp Institute
- Premiere Research Institute
- Emory University, Dept. of Neurology
- Dekalb Neurology Associates, LLC
- Department of Neurology - Indiana University Medical Center
- University of Kansas Medical Center, Department of Neurology
- Innovative Clinical Concepts
- Memory Enhancement Center of America, Inc.
- Global Medical Institutes
- Albuquerque Neuroscience, Inc.
- Neurological Associates of Albany, PC
- Columbia University Sergievsky Center
- AD-CARE, Monroe Community Hospital
- Raleigh Neurology Associates
- Neurology & Neuroscience Center of Ohio
- Medford Neurological and Spine Clinic
- Summit Research Newtwork, Inc.
- The Clinical Trial Center, LLC
- University of Pittsburgh Alzheimer Disease Research Clinic
- Butler Hospital, Memory and Aging Center
- Alliance for Neuro Research, LLC dba Absher Neurology, PA
- Clinical Neuroscience Research Associates, Inc-The Memory Clinic
- Glenrose Rehabilitation Hospital
- University of British Columbia Hospital, Division of Neurology
- Parkwood Hospital
- Sisters of Charity of Ottawa Health Service
- Kawartha Regional Memory Clinic
- Whitby Mental Health Memory Clinic
- Gerontion Research, Inc.
- Recherche Clinique de Neurologie (Hospital Maisonneuve Rosemont)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ELND005
Arm Description
Outcomes
Primary Outcome Measures
Treatment Emergent Adverse Events (TEAEs)
Safety and Tolerability was assessed by the incidence of Treatment Emergent Adverse Events (TEAEs)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00934050
Brief Title
ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's Disease
Official Title
A Long-Term Follow-Up Study of Oral ELND005 (AZD-103) in Subjects With Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OPKO Health, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ELND005
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ELND005 (scyllo-inositol)
Other Intervention Name(s)
scyllo-inositol
Intervention Description
Prior to 15Dec2009: ELND005 2000 mg PO BID for 48 weeks
After 15Dec2009: ELND005 250 mg PO BID for 48 weeks
Primary Outcome Measure Information:
Title
Treatment Emergent Adverse Events (TEAEs)
Description
Safety and Tolerability was assessed by the incidence of Treatment Emergent Adverse Events (TEAEs)
Time Frame
12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Banner Alzheimer's Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Sun Health Research Institute
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
University of Arizona, Health Sciences Center, Dept. of Neurology
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Margolin Brain Institute
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Collaborative NeuroScience Network, Inc.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Yale University School of Medicine, Alzheimer's Disease Research Unit
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Brain Matters Research
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Sunrise Clinical Research, Inc
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Roskamp Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
Premiere Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Emory University, Dept. of Neurology
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Dekalb Neurology Associates, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Department of Neurology - Indiana University Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kansas Medical Center, Department of Neurology
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Innovative Clinical Concepts
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Memory Enhancement Center of America, Inc.
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
Facility Name
Global Medical Institutes
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Albuquerque Neuroscience, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Neurological Associates of Albany, PC
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Columbia University Sergievsky Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
AD-CARE, Monroe Community Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Raleigh Neurology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Neurology & Neuroscience Center of Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Medford Neurological and Spine Clinic
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Summit Research Newtwork, Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
The Clinical Trial Center, LLC
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
University of Pittsburgh Alzheimer Disease Research Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Butler Hospital, Memory and Aging Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Alliance for Neuro Research, LLC dba Absher Neurology, PA
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Clinical Neuroscience Research Associates, Inc-The Memory Clinic
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Glenrose Rehabilitation Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5G 0B7
Country
Canada
Facility Name
University of British Columbia Hospital, Division of Neurology
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
Facility Name
Parkwood Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 5J1
Country
Canada
Facility Name
Sisters of Charity of Ottawa Health Service
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1N 5C8
Country
Canada
Facility Name
Kawartha Regional Memory Clinic
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9H 2P4
Country
Canada
Facility Name
Whitby Mental Health Memory Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Gerontion Research, Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6M 3Z5
Country
Canada
Facility Name
Recherche Clinique de Neurologie (Hospital Maisonneuve Rosemont)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's Disease
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