search
Back to results

ELND005 in Patients With Mild to Moderate Alzheimer's Disease

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo Control
ELND005
ELND005
ELND005
Sponsored by
OPKO Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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.
  • UCLA Alzheimer's Disease Center, Dept. of Neurology
  • UC Irvine Medical Center
  • UCSF Medical Center, Dept. of Neurology
  • Yale University School of Medicine, Alzheimer's Disease Research Unit
  • Georgetown University Medical Center, Dept. of Neurology
  • Brain Matters Research, Inc.
  • Sunrise Clinical Research, Inc
  • Miami Jewish Home and Hospital For The Aged
  • Avision Research Associates, LLC
  • Compass Research, LLC
  • Roskamp Institute
  • Neurology Clinical Research, Inc.
  • University of South Florida Suncoast Alzheimer's and Gerontology Center
  • 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
  • Brigham and Women's Hospital, Dept. of Neurology
  • University of Michigan, Taubman Health Care Center, Dept. of Neurology
  • University of Nevada School of Medicine
  • Comprehensive Clinical Research
  • The Memory Enhancement Center of America, Inc.
  • Global Medical Institutes
  • Albuquerque Neuroscience, Inc.
  • Upstate Clinical Research, LLC
  • Neurological Associates of Albany, PC
  • Mount Sinai Medical Center
  • 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.
  • Abington Neurological Associates, 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
  • Radiant Research San Antonio
  • University of Utah, Dept. of Neurology
  • Clinical Neuroscience Research Associates, Inc-The Memory Clinic
  • University of Vermont Medical Center, Fletcher Allen Health Care, Dept. of Neurology
  • University of Virginia Health System
  • Glenrose Rehabilitation Hospital
  • University of British Columbia Hospital, Division of Neurology
  • Hotel Dieu Hospital
  • Saint Joseph's Health Care London, Saint Joseph's Hospital, Dept. of Cognitive Neurology
  • Parkwood Hospital
  • Sisters of Charity of Ottawa Health Service
  • Kawartha Regional Memory Clinic
  • Toronto Memory Program
  • Whitby Mental Health Memory Clinic
  • Gerontion Research, Inc.
  • Neuro-Rive-Sud Memory Clinic
  • Recherche Clinique de Neurologie (Hospital Maisonneuve Rosemont)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
December 4, 2007
Last Updated
October 17, 2019
Sponsor
OPKO Health, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00568776
Brief Title
ELND005 in Patients With Mild to Moderate Alzheimer's Disease
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Safety and Efficacy Study of Oral ELND005 (AZD-103) in Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OPKO Health, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
353 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Active Comparator
Arm Title
4
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo Control
Other Intervention Name(s)
scyllo-inositol
Intervention Description
ELND005 matched placebo capsules for oral administration, bid for 78 weeks
Intervention Type
Drug
Intervention Name(s)
ELND005
Intervention Description
ELND005 capsules for oral administration at a dose of 2000 mg bid for 78 weeks
Intervention Type
Drug
Intervention Name(s)
ELND005
Other Intervention Name(s)
scyllo-inositol
Intervention Description
ELND005 capsules for oral administration at a dose of 250 mg bid for 78 weeks
Intervention Type
Drug
Intervention Name(s)
ELND005
Other Intervention Name(s)
scyllo-inositol
Intervention Description
ELND005 capsules for oral administration at a dose of 1000 mg bid for 78 weeks
Primary Outcome Measure Information:
Title
Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS)
Description
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.
Time Frame
Baseline and 78 weeks
Title
Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Per Protocol Set; PPS)
Description
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.
Time Frame
Baseline and 78 weeks
Title
Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Full Analysis Set; FAS)
Description
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.
Time Frame
Baseline and 78 weeks
Title
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)
Description
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.
Time Frame
Baseline and 78 weeks
Secondary Outcome Measure Information:
Title
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Score From Baseline to Week 78 (Full Analysis Set; FAS)
Description
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.
Time Frame
Baseline and 78 weeks
Title
Change in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score From Baseline to Week 78 (Full Analysis Set; FAS)
Description
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.
Time Frame
Baseline and 78 weeks
Title
Change in Neuropsychiatric Inventory (NPI) Score From Baseline to Week 78 (Full Analysis Set; FAS)
Description
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.
Time Frame
Baseline and 78 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
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
UCLA Alzheimer's Disease Center, Dept. of Neurology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UCSF Medical Center, Dept. of Neurology
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
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
Georgetown University Medical Center, Dept. of Neurology
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Facility Name
Brain Matters Research, Inc.
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
Miami Jewish Home and Hospital For The Aged
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Avision Research Associates, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Roskamp Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
Neurology Clinical Research, Inc.
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
University of South Florida Suncoast Alzheimer's and Gerontology Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33617
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
Brigham and Women's Hospital, Dept. of Neurology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan, Taubman Health Care Center, Dept. of Neurology
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Nevada School of Medicine
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Comprehensive Clinical Research
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
The 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
Upstate Clinical Research, LLC
City
Albany
State/Province
New York
ZIP/Postal Code
12205
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
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
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
Abington Neurological Associates, Inc.
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
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
Radiant Research San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Utah, Dept. of Neurology
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
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
University of Vermont Medical Center, Fletcher Allen Health Care, Dept. of Neurology
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
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
Hotel Dieu Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada
Facility Name
Saint Joseph's Health Care London, Saint Joseph's Hospital, Dept. of Cognitive Neurology
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
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
Toronto Memory Program
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B 2S7
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
Neuro-Rive-Sud Memory Clinic
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
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 in Patients With Mild to Moderate Alzheimer's Disease

We'll reach out to this number within 24 hrs