E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Agitation and Aggression in Moderate to severe Alzheimer's Disease. |
|
E.1.1.1 | Medical condition in easily understood language |
Agitation and Aggression in Patients with Alzheimer's Disease. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure (or up to 48 weeks across studies AG201 and AG251), in Moderate to Severe Alzheimer's Disease patients with agitation and aggression.
To evaluate the effects and persistence of effects of ELND005 on agitation and aggression and other assesments including neuropsychiatric symptons, cognitive status, patient's dependence status and caregiver distress. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate additional efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) endpoints. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Signed and dated written informed consent obtained in accordance with local regulations.
- Completes the Week 12 visit in study AG201 while taking their assigned does of study drug.
- Has no new medical condtraindication to continue participation in the study |
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Safety Endpoints:
-Incident and severty of treatment-emergent AEs, serious AEs, and withdrawls due to AEs.
-Changes in Baseline of Study AG201 to Week 36 of Study AG251 in the following safety assesments: vital sign measurments, weight, clinical laboratory assessments, physical and neurological examinations, and ECGs. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Efficacy endpoints:
Changes in baseline to Week 36 in Study AG251 (for all patients), and changes from baseline in Study AG201 to Week 36 of Study AG251 (for patients in Group 1) in:
-NPI-C combined agitation and aggression subscores
-mADCS-CGIC agitation domain scores (CGIC)
-NPI-C subitems of agitation, aggression, apathy, depression/dysphoria, anxiety.
-NPI subitems of aberrant motor behaviour, nighttime behavior, disinhibition, delusions and hallucinations.
-Total NPI score.
PK/PD Assessments/Endpoints
Relationship between PK parmaeters and selected safety, efficacy, and PD outcome measures. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 18 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
France |
Spain |
United Kingdom |
United States |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
A study patient will be considered to have completed Study AG251 at the end of the 36 weeks of treatment (ie, Week 36 or End of Study [EOS]).
This definition is based on the timepoint for primary endpoint assessment. A safety follow-up phase of 6 weeks will occur following the Week 36 or End of Study [EOS] visit. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |