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Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

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

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Agitation, Aggression, patients

Eligibility Criteria

50 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of Probable AD according to the National Institute on Aging- Alzheimer's Association (NIA-AA) guidelines (McKhann et al 2011).
  • MMSE score of 5 to 24 (inclusive) at the Screening Visit.
  • Has clinically significant agitation/aggression defined as Neuropsychiatric Inventory (NPI)-agitation/aggression subscore of ≥4.
  • No response or suboptimal response to standard nonpharmacological interventions.

Exclusion Criteria:

  • The agitation/aggression is attributable to concomitant medications, environmental conditions, or active medical or psychiatric condition.
  • Current diagnosis of major depressive disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision (DSM IV TR).
  • Has persistent and distressing psychotic symptoms (delusion and/or hallucinations) that require psychiatric hospitalization.

Sites / Locations

  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ELND005

Placebo

Arm Description

ELND005 film coated tablets, BID for 12 weeks

Matched placebo BID for 12 weeks

Outcomes

Primary Outcome Measures

Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A).
The NPI-C (de Medeiros et al 2010) is a validated and reliable behavioral measure that assesses psychopathology in dementia subjects. It evaluates 14 neuropsychiatric disturbances common in dementia.Higher scores on the NPI-C are associated with a greater clinical severity of symptoms. The NPI-C Agitation and Aggression score ranges from 0-63. The analysis of the NPI-C A+A score was performed on the mITT population.

Secondary Outcome Measures

Change From Baseline in Modified-ADCS-CGIC Agitation Scores
The Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) is a widely used scale for the global assessment of change in AD trials.It is a 7-point Likert scale that ranges from marked improvement scored as 1 to marked worsening scored as 7, with no change scored as 4. The range is from 1 to 7. Higher scores indicate worsening agitation.
Change From Baseline in NPI Total Scores
The NPI (Cummings et al 1994) is a behavioral measure that assesses psychopathology in dementia subjects. It evaluates 12 neuropsychiatric disturbances common in dementia: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, nighttime behavior disturbances, and appetite and eating abnormalities. Higher scores on the NPI are associated with greater frequency and severity of symptoms. The scale range is 0-144.
Change From Baseline in MMSE Scores
The Mini-Mental State Exam (MMSE) (Folstein et al 1975) is a brief cognitive test assessing general cognitive function that has been employed in numerous clinical trials of products approved for the treatment of AD. The score can range from 0 to 30, with lower scores indicating greater impairment in function.
Change From Baseline in ADCS-ADL Scores
The Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) (Galasko et al 1997) is a functional assessment that measures instrumental and basic activities of daily living. The total score for the 23-item ADCS-ADL ranges from 0 to 78 points, with lower scores indicating greater impairment in function.

Full Information

First Posted
November 25, 2012
Last Updated
October 17, 2019
Sponsor
OPKO Health, Inc.
Collaborators
Elan Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01735630
Brief Title
Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
Official Title
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Efficacy and Safety Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients With Moderate to Severe Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary purpose of this study is to determine whether ELND005 is effective in treating symptoms of agitation and aggression in patients with Alzheimer's disease

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Agitation, Aggression, patients

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
ELND005
Arm Type
Experimental
Arm Description
ELND005 film coated tablets, BID for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matched placebo BID for 12 weeks
Intervention Type
Drug
Intervention Name(s)
ELND005
Other Intervention Name(s)
Scyllo-inositol
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A).
Description
The NPI-C (de Medeiros et al 2010) is a validated and reliable behavioral measure that assesses psychopathology in dementia subjects. It evaluates 14 neuropsychiatric disturbances common in dementia.Higher scores on the NPI-C are associated with a greater clinical severity of symptoms. The NPI-C Agitation and Aggression score ranges from 0-63. The analysis of the NPI-C A+A score was performed on the mITT population.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Modified-ADCS-CGIC Agitation Scores
Description
The Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) is a widely used scale for the global assessment of change in AD trials.It is a 7-point Likert scale that ranges from marked improvement scored as 1 to marked worsening scored as 7, with no change scored as 4. The range is from 1 to 7. Higher scores indicate worsening agitation.
Time Frame
Week 12
Title
Change From Baseline in NPI Total Scores
Description
The NPI (Cummings et al 1994) is a behavioral measure that assesses psychopathology in dementia subjects. It evaluates 12 neuropsychiatric disturbances common in dementia: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, nighttime behavior disturbances, and appetite and eating abnormalities. Higher scores on the NPI are associated with greater frequency and severity of symptoms. The scale range is 0-144.
Time Frame
Week 12
Title
Change From Baseline in MMSE Scores
Description
The Mini-Mental State Exam (MMSE) (Folstein et al 1975) is a brief cognitive test assessing general cognitive function that has been employed in numerous clinical trials of products approved for the treatment of AD. The score can range from 0 to 30, with lower scores indicating greater impairment in function.
Time Frame
Week 12
Title
Change From Baseline in ADCS-ADL Scores
Description
The Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) (Galasko et al 1997) is a functional assessment that measures instrumental and basic activities of daily living. The total score for the 23-item ADCS-ADL ranges from 0 to 78 points, with lower scores indicating greater impairment in function.
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Probable AD according to the National Institute on Aging- Alzheimer's Association (NIA-AA) guidelines (McKhann et al 2011). MMSE score of 5 to 24 (inclusive) at the Screening Visit. Has clinically significant agitation/aggression defined as Neuropsychiatric Inventory (NPI)-agitation/aggression subscore of ≥4. No response or suboptimal response to standard nonpharmacological interventions. Exclusion Criteria: The agitation/aggression is attributable to concomitant medications, environmental conditions, or active medical or psychiatric condition. Current diagnosis of major depressive disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision (DSM IV TR). Has persistent and distressing psychotic symptoms (delusion and/or hallucinations) that require psychiatric hospitalization.
Facility Information:
Facility Name
TransitionTIL Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33449
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Oakland Park
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31419
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Bangor
State/Province
Maine
ZIP/Postal Code
04402
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Easton
State/Province
Maryland
ZIP/Postal Code
21601
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Winchester
State/Province
Massachusetts
ZIP/Postal Code
01890
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Paw Paw
State/Province
Michigan
ZIP/Postal Code
49079
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55130
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Stratford
State/Province
New Jersey
ZIP/Postal Code
08084
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19401
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
TransitionTIL Investigational Site
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Port Royal
State/Province
South Carolina
ZIP/Postal Code
29935
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
TransitionTIL Investigational Site
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N-4Z6
Country
Canada
Facility Name
TransitionTIL Investigational Site
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 3G8
Country
Canada
Facility Name
TransitionTIL Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
TransitionTIL Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6M 3Z5
Country
Canada
Facility Name
TransitionTIL Investigational Site
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 1A5
Country
Canada
Facility Name
TransitionTIL Investigational Site
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
TransitionTIL Investigational Site
City
Getxo
State/Province
Biscay
ZIP/Postal Code
48993
Country
Spain
Facility Name
TransitionTIL Investigational Site
City
Barcelona
ZIP/Postal Code
08029
Country
Spain
Facility Name
TransitionTIL Investigational Site
City
Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
TransitionTIL Investigational Site
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Facility Name
TransitionTIL Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
TransitionTIL Investigational Site
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
TransitionTIL Investigational Site
City
Swindon
ZIP/Postal Code
SN3 6BW
Country
United Kingdom

12. IPD Sharing Statement

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Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease

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