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

October 17, 2019 updated by: OPKO Health, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alberta
      • Calgary, Alberta, Canada, T2N-4Z6
        • TransitionTIL Investigational Site
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 3G8
        • TransitionTIL Investigational Site
    • Ontario
      • Toronto, Ontario, Canada, M6M 3Z5
        • TransitionTIL Investigational Site
      • Toronto, Ontario, Canada, M4N 3M5
        • TransitionTIL Investigational Site
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 1A5
        • TransitionTIL Investigational Site
      • Barcelona, Spain, 08029
        • TransitionTIL Investigational Site
      • Barcelona, Spain, 08221
        • TransitionTIL Investigational Site
      • Burgos, Spain, 09006
        • TransitionTIL Investigational Site
      • Madrid, Spain, 28040
        • TransitionTIL Investigational Site
    • Alicante
      • Elche, Alicante, Spain, 03203
        • TransitionTIL Investigational Site
    • Biscay
      • Getxo, Biscay, Spain, 48993
        • TransitionTIL Investigational Site
      • Bath, United Kingdom, BA1 3NG
        • TransitionTIL Investigational Site
      • Swindon, United Kingdom, SN3 6BW
        • TransitionTIL Investigational Site
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • TransitionTIL Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • TransitionTIL Investigational Site
      • Phoenix, Arizona, United States, 85006
        • TransitionTIL Investigational Site
    • California
      • Encino, California, United States, 91316
        • TransitionTIL Investigational Site
      • Escondido, California, United States, 92025
        • TransitionTIL Investigational Site
      • Fresno, California, United States, 93710
        • TransitionTIL Investigational Site
      • Irvine, California, United States, 92697
        • TransitionTIL Investigational Site
      • Long Beach, California, United States, 90806
        • TransitionTIL Investigational Site
      • Los Alamitos, California, United States, 90720
        • TransitionTIL Investigational Site
      • Los Angeles, California, United States, 90073
        • TransitionTIL Investigational Site
      • Newport Beach, California, United States, 92663
        • TransitionTIL Investigational Site
      • Santa Ana, California, United States, 92701
        • TransitionTIL Investigational Site
    • Connecticut
      • Norwalk, Connecticut, United States, 06851
        • TransitionTIL Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20057
        • TransitionTIL Investigational Site
    • Florida
      • Atlantis, Florida, United States, 33462
        • TransitionTIL Investigational Site
      • Deerfield Beach, Florida, United States, 33064
        • TransitionTIL Investigational Site
      • Delray Beach, Florida, United States, 33445
        • TransitionTIL Investigational Site
      • Lake Worth, Florida, United States, 33449
        • TransitionTIL Investigational Site
      • Miami, Florida, United States, 33137
        • TransitionTIL Investigational Site
      • Oakland Park, Florida, United States, 33334
        • TransitionTIL Investigational Site
      • Orlando, Florida, United States, 32806
        • TransitionTIL Investigational Site
      • Ormond Beach, Florida, United States, 32174
        • TransitionTIL Investigational Site
      • Port Charlotte, Florida, United States, 33952
        • TransitionTIL Investigational Site
      • Sarasota, Florida, United States, 34243
        • TransitionTIL Investigational Site
      • Sunrise, Florida, United States, 33351
        • TransitionTIL Investigational Site
    • Georgia
      • Columbus, Georgia, United States, 31909
        • TransitionTIL Investigational Site
      • Savannah, Georgia, United States, 31419
        • TransitionTIL Investigational Site
    • Illinois
      • Springfield, Illinois, United States, 62702
        • TransitionTIL Investigational Site
    • Maine
      • Bangor, Maine, United States, 04402
        • TransitionTIL Investigational Site
    • Maryland
      • Easton, Maryland, United States, 21601
        • TransitionTIL Investigational Site
    • Massachusetts
      • Winchester, Massachusetts, United States, 01890
        • TransitionTIL Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • TransitionTIL Investigational Site
      • Paw Paw, Michigan, United States, 49079
        • TransitionTIL Investigational Site
    • Minnesota
      • Saint Paul, Minnesota, United States, 55130
        • TransitionTIL Investigational Site
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • TransitionTIL Investigational Site
    • New Jersey
      • Stratford, New Jersey, United States, 08084
        • TransitionTIL Investigational Site
    • New York
      • Rochester, New York, United States, 14620
        • TransitionTIL Investigational Site
      • Rochester, New York, United States, 14623
        • TransitionTIL Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • TransitionTIL Investigational Site
      • Charlotte, North Carolina, United States, 28209
        • TransitionTIL Investigational Site
      • Durham, North Carolina, United States, 27710
        • TransitionTIL Investigational Site
      • Wilmington, North Carolina, United States, 28401
        • TransitionTIL Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • TransitionTIL Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • TransitionTIL Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97225
        • TransitionTIL Investigational Site
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • TransitionTIL Investigational Site
      • Jenkintown, Pennsylvania, United States, 19046
        • TransitionTIL Investigational Site
      • Norristown, Pennsylvania, United States, 19401
        • TransitionTIL Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • TransitionTIL Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • TransitionTIL Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • TransitionTIL Investigational Site
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • TransitionTIL Investigational Site
      • Port Royal, South Carolina, United States, 29935
        • TransitionTIL Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • TransitionTIL Investigational Site
    • Texas
      • DeSoto, Texas, United States, 75115
        • TransitionTIL Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23230
        • TransitionTIL Investigational Site
    • Washington
      • Bellevue, Washington, United States, 98007
        • TransitionTIL Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ELND005
ELND005 film coated tablets, BID for 12 weeks
Other Names:
  • Scyllo-inositol
PLACEBO_COMPARATOR: Placebo
Matched placebo BID for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A).
Time Frame: Week 12
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.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Modified-ADCS-CGIC Agitation Scores
Time Frame: Week 12
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.
Week 12
Change From Baseline in NPI Total Scores
Time Frame: Week 12
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.
Week 12
Change From Baseline in MMSE Scores
Time Frame: Week 12
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.
Week 12
Change From Baseline in ADCS-ADL Scores
Time Frame: Week 12
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.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

November 25, 2012

First Submitted That Met QC Criteria

November 27, 2012

First Posted (ESTIMATE)

November 28, 2012

Study Record Updates

Last Update Posted (ACTUAL)

October 21, 2019

Last Update Submitted That Met QC Criteria

October 17, 2019

Last Verified

October 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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