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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • 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
  • Spain
      • 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
  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • TransitionTIL Investigational Site
      • Swindon, United Kingdom, SN3 6BW
        • TransitionTIL Investigational Site
  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: ELND005
ELND005 film coated tablets, BID for 12 weeks
Drug: ELND005
Other Names:
  • Scyllo-inositol
PLACEBO_COMPARATOR: Placebo
Matched placebo BID for 12 weeks
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
OPKO Health, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Elan Pharmaceuticals

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ELND005-AG201
  • 2012-004299-20 (EUDRACT_NUMBER)

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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