Alzheimer's Disease
Conditions
Keywords
Agitation, Aggression, AD patients
Brief 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.
Interventions
DRUGGroup 1 ELND005
DRUGGroup 2 ELND005
Sponsors
Elan Pharmaceuticals
OPKO Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Treatment Emergent Adverse Events | 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. |
Countries
Canada, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ELND005/ELND005 Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251 | 150 |
| Placebo/ELND005 Patients who received Placebo in AG201 and received ELND005 in this extension study AG251 | 146 |
| Total | 296 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 11 | 8 |
| Overall Study | Death | 4 | 3 |
| Overall Study | Lost to Follow-up | 1 | 3 |
| Overall Study | Physician Decision | 4 | 2 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Sponsor Decision | 52 | 43 |
| Overall Study | Withdrawal by Subject | 18 | 15 |
Baseline characteristics
| Characteristic | Placebo/ELND005 | Total | ELND005/ELND005 |
|---|---|---|---|
| Age, Continuous | 75.9 years STANDARD_DEVIATION 8.7 | 76.2 years STANDARD_DEVIATION 8.3 | 76.6 years STANDARD_DEVIATION 7.9 |
| Race/Ethnicity, Customized Asian | 1 participants | 2 participants | 1 participants |
| Race/Ethnicity, Customized Black or African American | 17 participants | 27 participants | 10 participants |
| Race/Ethnicity, Customized Other | 1 participants | 2 participants | 1 participants |
| Race/Ethnicity, Customized White | 127 participants | 265 participants | 138 participants |
| Region of Enrollment Europe | 12 participants | 25 participants | 13 participants |
| Region of Enrollment North America | 134 participants | 271 participants | 137 participants |
| Sex: Female, Male Female | 81 Participants | 165 Participants | 84 Participants |
| Sex: Female, Male Male | 65 Participants | 131 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 41 / 150 | 26 / 146 |
| serious Total, serious adverse events | 29 / 150 | 26 / 146 |
Outcome results
Primary
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.
Time frame: 36 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ELND005/ELND005 | Number of Participants Experiencing Treatment Emergent Adverse Events | 105 participants |
| Placebo/ELND005 | Number of Participants Experiencing Treatment Emergent Adverse Events | 91 participants |