Alzheimer's DiseasePhase 2NCT01766336
A 36-Week Safety Extension Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
A Phase 2 study testing Group 1 ELND005 and Group 2 ELND005 in people with Alzheimer's Disease, run by OPKO Health, Inc. at 46 sites in 4 countries.
Trial summary
To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure, in Moderate to Severe AD patients with agitation and aggression. 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?
- Group 1 ELND005 and Group 2 ELND005
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 46 sitesin 4 countries
- Study dates
- Jan 2013to Aug 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
- Complete Week 12 visit of AG201
- Both patient and study partner/caregiver are willing and able to participate in all scheduled evaluations and complete all required tests
Who cannot join
- Is currently using any other investigational or experimental drugs or devices
- Has significant worsening of medical conditions or dementia such that it may preclude completion of this safety extension study
Trial locations and contacts
46 sites in 4 countries.
46 sites in 4 countries
United States40 sites
TransitionTIL Investigational Site
Abington, Pennsylvania, 19001
TransitionTIL Investigational Site
Atlantis, Florida, 33462
TransitionTIL Investigational Site
Bellevue, Washington, 98007
TransitionTIL Investigational Site
Birmingham, Alabama, 35294
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
Jenkintown, Pennsylvania, 19046
TransitionTIL Investigational Site
Lake Worth, Florida, 33449
TransitionTIL Investigational Site
Long Beach, California, 90806
TransitionTIL Investigational Site
Newport Beach, California, 92658
TransitionTIL Investigational Site
Norristown, Pennsylvania, 19401
TransitionTIL Investigational Site
Norwalk, Connecticut, 06851
TransitionTIL Investigational Site
Oakland Park, Florida, 33334
TransitionTIL Investigational Site
Oklahoma City, Oklahoma, 73112
TransitionTIL Investigational Site
Orange, California, 92868
TransitionTIL Investigational Site
Orlando, Florida, 32806
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, 97225-6625
TransitionTIL Investigational Site
Rochester, New York, 14620
TransitionTIL Investigational Site
Rochester, New York, 14623
TransitionTIL Investigational Site
Saint Paul, Minnesota, 55130
TransitionTIL Investigational Site
Sarasota, Florida, 34243
TransitionTIL Investigational Site
Savannah, Georgia, 31419
TransitionTIL Investigational Site
Springfield, Illinois, 62702
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
Spain4 sites
TransitionTIL Investigational Site
Barcelona, 08028
TransitionTIL Investigational Site
Elche, Alicante, 03203
TransitionTIL Investigational Site
Madrid, 28040
TransitionTIL Investigational Site
Terrassa, Barcelona, 08221
United Kingdom1 site
TransitionTIL Investigational Site
Swindon, Wiltshire, SN3 6BW
About this study
Official title: A 36-Week Safety Extension Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients With Moderate to Severe Alzheimer's Disease
To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure, in Moderate to Severe AD patients with agitation and aggression.
- Conditions
- Alzheimer's Disease
- Being tested
- Group 1 ELND005, Group 2 ELND005
- Keywords
- Agitation, Aggression, AD 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.
Group 1 ELND005Drug
Group 2 ELND005Drug
| Study group | Role | What they receive |
|---|---|---|
| Group 1 ELND005/ELND005 | Experimental | Patients who received ELND005 during Study AG201 will continue on the same maintenance dose for 36 weeks. Receives: Drug: Group 1 ELND005 |
| Group 2 PLACEBO/ELND005 | Experimental | Patients who received placebo during Study AG201 will receive ELND005 at the same dosing regimen as the active group in Study AG201 for 36 weeks. Receives: Drug: Group 2 ELND005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Treatment Emergent Adverse Events
To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure, in Moderate to Severe AD patients with agitation and aggression.
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2015
- Study completionAug 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
- 296 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
- NCT01766336
- Sponsor's protocol ID
- ELND005-AG251
- Other IDs
- 2012-005524-15
- Status last verified
- Oct 2019
- First submitted
- 8 Jan 2013
- 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 36-Week Safety Extension Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients With Moderate to Severe Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01766336
- Acronym / sponsor ID
- ELND005-AG251
- Conditions
- Alzheimer's Disease
- Keywords
- Agitation, Aggression, AD patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 296 participants (actual)
- Lead sponsor
- OPKO Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Elan Pharmaceuticals
- Study start
- Jan 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 11 Jan 2013 (estimated)
- Results
- Posted 13 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure, in Moderate to Severe AD patients with agitation and aggression.
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 |
|---|---|---|
| Group 1 ELND005/ELND005 | Experimental | Drug: Group 1 ELND005Patients who received ELND005 during Study AG201 will continue on the same maintenance dose for 36 weeks. |
| Group 2 PLACEBO/ELND005 | Experimental | Drug: Group 2 ELND005Patients who received placebo during Study AG201 will receive ELND005 at the same dosing regimen as the active group in Study AG201 for 36 weeks. |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Complete Week 12 visit of AG201
- Both patient and study partner/caregiver are willing and able to participate in all scheduled evaluations and complete all required tests
Key exclusion criteria (2 listed)
- Is currently using any other investigational or experimental drugs or devices
- Has significant worsening of medical conditions or dementia such that it may preclude completion of this safety extension study
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 |
|---|---|---|
| Group 1 ELND005 | Drug | Group 1 ELND005/ELND005 |
| Group 2 ELND005 | Drug | Group 2 PLACEBO/ELND005 |
Primary outcome
Number of Participants Experiencing Treatment Emergent Adverse Events
Time frame: 36 weeks
To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure, in Moderate to Severe AD patients with agitation and aggression.
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.
46 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 Group 1 ELND005 and Group 2 ELND005 in people with Alzheimer's Disease, run by OPKO Health, Inc. at 46 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 2 inclusion and 2 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: stopped early, 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 46 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. 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 13 May 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?
Number of Participants Experiencing Treatment Emergent Adverse Events (time frame: 36 weeks). 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.