- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01735630
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
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Alberta
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Calgary, Alberta, Canada, T2N-4Z6
- TransitionTIL Investigational Site
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British Columbia
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Kelowna, British Columbia, Canada, V1Y 3G8
- TransitionTIL Investigational Site
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Ontario
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Toronto, Ontario, Canada, M6M 3Z5
- TransitionTIL Investigational Site
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Toronto, Ontario, Canada, M4N 3M5
- TransitionTIL Investigational Site
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 1A5
- TransitionTIL Investigational Site
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Barcelona, Spain, 08029
- TransitionTIL Investigational Site
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Barcelona, Spain, 08221
- TransitionTIL Investigational Site
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Burgos, Spain, 09006
- TransitionTIL Investigational Site
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Madrid, Spain, 28040
- TransitionTIL Investigational Site
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Alicante
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Elche, Alicante, Spain, 03203
- TransitionTIL Investigational Site
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Biscay
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Getxo, Biscay, Spain, 48993
- TransitionTIL Investigational Site
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Bath, United Kingdom, BA1 3NG
- TransitionTIL Investigational Site
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Swindon, United Kingdom, SN3 6BW
- TransitionTIL Investigational Site
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Alabama
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Birmingham, Alabama, United States, 35294
- TransitionTIL Investigational Site
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Arizona
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Phoenix, Arizona, United States, 85004
- TransitionTIL Investigational Site
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Phoenix, Arizona, United States, 85006
- TransitionTIL Investigational Site
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California
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Encino, California, United States, 91316
- TransitionTIL Investigational Site
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Escondido, California, United States, 92025
- TransitionTIL Investigational Site
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Fresno, California, United States, 93710
- TransitionTIL Investigational Site
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Irvine, California, United States, 92697
- TransitionTIL Investigational Site
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Long Beach, California, United States, 90806
- TransitionTIL Investigational Site
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Los Alamitos, California, United States, 90720
- TransitionTIL Investigational Site
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Los Angeles, California, United States, 90073
- TransitionTIL Investigational Site
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Newport Beach, California, United States, 92663
- TransitionTIL Investigational Site
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Santa Ana, California, United States, 92701
- TransitionTIL Investigational Site
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Connecticut
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Norwalk, Connecticut, United States, 06851
- TransitionTIL Investigational Site
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District of Columbia
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Washington, District of Columbia, United States, 20057
- TransitionTIL Investigational Site
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Florida
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Atlantis, Florida, United States, 33462
- TransitionTIL Investigational Site
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Deerfield Beach, Florida, United States, 33064
- TransitionTIL Investigational Site
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Delray Beach, Florida, United States, 33445
- TransitionTIL Investigational Site
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Lake Worth, Florida, United States, 33449
- TransitionTIL Investigational Site
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Miami, Florida, United States, 33137
- TransitionTIL Investigational Site
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Oakland Park, Florida, United States, 33334
- TransitionTIL Investigational Site
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Orlando, Florida, United States, 32806
- TransitionTIL Investigational Site
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Ormond Beach, Florida, United States, 32174
- TransitionTIL Investigational Site
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Port Charlotte, Florida, United States, 33952
- TransitionTIL Investigational Site
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Sarasota, Florida, United States, 34243
- TransitionTIL Investigational Site
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Sunrise, Florida, United States, 33351
- TransitionTIL Investigational Site
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Georgia
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Columbus, Georgia, United States, 31909
- TransitionTIL Investigational Site
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Savannah, Georgia, United States, 31419
- TransitionTIL Investigational Site
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Illinois
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Springfield, Illinois, United States, 62702
- TransitionTIL Investigational Site
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Maine
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Bangor, Maine, United States, 04402
- TransitionTIL Investigational Site
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Maryland
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Easton, Maryland, United States, 21601
- TransitionTIL Investigational Site
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Massachusetts
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Winchester, Massachusetts, United States, 01890
- TransitionTIL Investigational Site
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Michigan
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Ann Arbor, Michigan, United States, 48105
- TransitionTIL Investigational Site
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Paw Paw, Michigan, United States, 49079
- TransitionTIL Investigational Site
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Minnesota
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Saint Paul, Minnesota, United States, 55130
- TransitionTIL Investigational Site
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Mississippi
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Hattiesburg, Mississippi, United States, 39401
- TransitionTIL Investigational Site
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New Jersey
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Stratford, New Jersey, United States, 08084
- TransitionTIL Investigational Site
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New York
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Rochester, New York, United States, 14620
- TransitionTIL Investigational Site
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Rochester, New York, United States, 14623
- TransitionTIL Investigational Site
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North Carolina
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Charlotte, North Carolina, United States, 28211
- TransitionTIL Investigational Site
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Charlotte, North Carolina, United States, 28209
- TransitionTIL Investigational Site
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Durham, North Carolina, United States, 27710
- TransitionTIL Investigational Site
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Wilmington, North Carolina, United States, 28401
- TransitionTIL Investigational Site
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Winston-Salem, North Carolina, United States, 27103
- TransitionTIL Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
- TransitionTIL Investigational Site
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Oregon
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Portland, Oregon, United States, 97225
- TransitionTIL Investigational Site
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Pennsylvania
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Abington, Pennsylvania, United States, 19001
- TransitionTIL Investigational Site
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Jenkintown, Pennsylvania, United States, 19046
- TransitionTIL Investigational Site
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Norristown, Pennsylvania, United States, 19401
- TransitionTIL Investigational Site
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Philadelphia, Pennsylvania, United States, 19104
- TransitionTIL Investigational Site
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Philadelphia, Pennsylvania, United States, 19107
- TransitionTIL Investigational Site
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Pittsburgh, Pennsylvania, United States, 15213
- TransitionTIL Investigational Site
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South Carolina
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North Charleston, South Carolina, United States, 29406
- TransitionTIL Investigational Site
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Port Royal, South Carolina, United States, 29935
- TransitionTIL Investigational Site
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Tennessee
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Nashville, Tennessee, United States, 37212
- TransitionTIL Investigational Site
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Texas
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DeSoto, Texas, United States, 75115
- TransitionTIL Investigational Site
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Virginia
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Richmond, Virginia, United States, 23230
- TransitionTIL Investigational Site
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Washington
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Bellevue, Washington, United States, 98007
- TransitionTIL Investigational Site
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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 |
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EXPERIMENTAL: ELND005
ELND005 film coated tablets, BID for 12 weeks
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Other Names:
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PLACEBO_COMPARATOR: Placebo
Matched placebo BID for 12 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A).
Time Frame: Week 12
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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.
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Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Modified-ADCS-CGIC Agitation Scores
Time Frame: Week 12
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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.
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Week 12
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Change From Baseline in NPI Total Scores
Time Frame: Week 12
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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.
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Week 12
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Change From Baseline in MMSE Scores
Time Frame: Week 12
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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.
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Week 12
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Change From Baseline in ADCS-ADL Scores
Time Frame: Week 12
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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.
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Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dyskinesias
- Psychomotor Disorders
- Dementia
- Tauopathies
- Aggression
- Psychomotor Agitation
- Alzheimer Disease
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Vitamin B Complex
- Inositol
Other Study ID 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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