Alzheimer's DiseasePhase 2NCT01735630
Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
A Phase 2 study testing ELND005 in people with Alzheimer's Disease, run by OPKO Health, Inc. at 70 sites in 4 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- ELND005
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 70 sitesin 4 countries
- Study dates
- Nov 2012to May 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
70 sites in 4 countries.
70 sites in 4 countries
United States57 sites
TransitionTIL Investigational Site
Abington, Pennsylvania, 19001
TransitionTIL Investigational Site
Ann Arbor, Michigan, 48105
TransitionTIL Investigational Site
Atlantis, Florida, 33462
TransitionTIL Investigational Site
Bangor, Maine, 04402
TransitionTIL Investigational Site
Bellevue, Washington, 98007
TransitionTIL Investigational Site
Birmingham, Alabama, 35294
TransitionTIL Investigational Site
Charlotte, North Carolina, 28209
TransitionTIL Investigational Site
Charlotte, North Carolina, 28211
TransitionTIL Investigational Site
Columbus, Georgia, 31909
TransitionTIL Investigational Site
Deerfield Beach, Florida, 33064
TransitionTIL Investigational Site
Delray Beach, Florida, 33445
TransitionTIL Investigational Site
DeSoto, Texas, 75115
TransitionTIL Investigational Site
Durham, North Carolina, 27710
TransitionTIL Investigational Site
Easton, Maryland, 21601
TransitionTIL Investigational Site
Encino, California, 91316
TransitionTIL Investigational Site
Escondido, California, 92025
TransitionTIL Investigational Site
Fresno, California, 93710
TransitionTIL Investigational Site
Hattiesburg, Mississippi, 39401
TransitionTIL Investigational Site
Irvine, California, 92697
TransitionTIL Investigational Site
Jenkintown, Pennsylvania, 19046
TransitionTIL Investigational Site
Lake Worth, Florida, 33449
TransitionTIL Investigational Site
Long Beach, California, 90806
TransitionTIL Investigational Site
Los Alamitos, California, 90720
TransitionTIL Investigational Site
Los Angeles, California, 90073
TransitionTIL Investigational Site
Miami, Florida, 33137
TransitionTIL Investigational Site
Nashville, Tennessee, 37212
TransitionTIL Investigational Site
Newport Beach, California, 92663
TransitionTIL Investigational Site
Norristown, Pennsylvania, 19401
TransitionTIL Investigational Site
North Charleston, South Carolina, 29406
TransitionTIL Investigational Site
Norwalk, Connecticut, 06851
TransitionTIL Investigational Site
Oakland Park, Florida, 33334
TransitionTIL Investigational Site
Oklahoma City, Oklahoma, 73112
TransitionTIL Investigational Site
Orlando, Florida, 32806
TransitionTIL Investigational Site
Ormond Beach, Florida, 32174
TransitionTIL Investigational Site
Paw Paw, Michigan, 49079
TransitionTIL Investigational Site
Philadelphia, Pennsylvania, 19104
TransitionTIL Investigational Site
Philadelphia, Pennsylvania, 19107
TransitionTIL Investigational Site
Phoenix, Arizona, 85004
TransitionTIL Investigational Site
Phoenix, Arizona, 85006
TransitionTIL Investigational Site
Pittsburgh, Pennsylvania, 15213
TransitionTIL Investigational Site
Port Charlotte, Florida, 33952
TransitionTIL Investigational Site
Port Royal, South Carolina, 29935
TransitionTIL Investigational Site
Portland, Oregon, 97225
TransitionTIL Investigational Site
Richmond, Virginia, 23230
TransitionTIL Investigational Site
Rochester, New York, 14620
TransitionTIL Investigational Site
Rochester, New York, 14623
TransitionTIL Investigational Site
Saint Paul, Minnesota, 55130
TransitionTIL Investigational Site
Santa Ana, California, 92701
TransitionTIL Investigational Site
Sarasota, Florida, 34243
TransitionTIL Investigational Site
Savannah, Georgia, 31419
TransitionTIL Investigational Site
Springfield, Illinois, 62702
TransitionTIL Investigational Site
Stratford, New Jersey, 08084
TransitionTIL Investigational Site
Sunrise, Florida, 33351
TransitionTIL Investigational Site
Washington D.C., District of Columbia, 20057
TransitionTIL Investigational Site
Wilmington, North Carolina, 28401
TransitionTIL Investigational Site
Winchester, Massachusetts, 01890
TransitionTIL Investigational Site
Winston-Salem, North Carolina, 27103
Spain6 sites
TransitionTIL Investigational Site
Barcelona, 08029
TransitionTIL Investigational Site
Barcelona, 08221
TransitionTIL Investigational Site
Burgos, 09006
TransitionTIL Investigational Site
Elche, Alicante, 03203
TransitionTIL Investigational Site
Getxo, Biscay, 48993
TransitionTIL Investigational Site
Madrid, 28040
Canada5 sites
TransitionTIL Investigational Site
Calgary, Alberta, T2N-4Z6
TransitionTIL Investigational Site
Kelowna, British Columbia, V1Y 3G8
TransitionTIL Investigational Site
Regina, Saskatchewan, S4T 1A5
TransitionTIL Investigational Site
Toronto, Ontario, M4N 3M5
TransitionTIL Investigational Site
Toronto, Ontario, M6M 3Z5
United Kingdom2 sites
TransitionTIL Investigational Site
Bath, BA1 3NG
TransitionTIL Investigational Site
Swindon, SN3 6BW
About this study
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
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
- Conditions
- Alzheimer's Disease
- Being tested
- ELND005, Placebo
- Keywords
- Agitation, Aggression, patients
- Medical subject headings
- Alzheimer Disease, Psychomotor Agitation, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELND005Drug
Also called Scyllo-inositol
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| ELND005 | Experimental | ELND005 film coated tablets, BID for 12 weeks Receives: Drug: ELND005 |
| Placebo | Placebo comparator | Matched placebo BID for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12
Secondary outcomes (4)
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.
Measured: Week 12
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.
Measured: Week 12
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.
Measured: Week 12
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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- OPKO Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Elan Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735630
- Sponsor's protocol ID
- ELND005-AG201
- Other IDs
- 2012-004299-20
- Status last verified
- Oct 2019
- First submitted
- 25 Nov 2012
- Last updated
- 21 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01735630
- Acronym / sponsor ID
- ELND005-AG201
- Conditions
- Alzheimer's Disease
- Keywords
- Agitation, Aggression, patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- OPKO Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Elan Pharmaceuticals
- Study start
- Nov 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 28 Nov 2012 (estimated)
- Results
- Posted 15 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELND005 | Experimental | Drug: ELND005ELND005 film coated tablets, BID for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboMatched placebo BID for 12 weeks |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELND005Also: Scyllo-inositol | Drug | ELND005 |
| Placebo | Drug | Placebo |
Primary outcome
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.
4 secondary outcomes
Change From Baseline in Modified-ADCS-CGIC Agitation Scores
Time frame: Week 12
Change From Baseline in NPI Total Scores
Time frame: Week 12
Change From Baseline in MMSE Scores
Time frame: Week 12
Change From Baseline in ADCS-ADL Scores
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
70 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ELND005 in people with Alzheimer's Disease, run by OPKO Health, Inc. at 70 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in United States, Spain, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A). (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019.