Agitation Associated with Dementia of the Alzheimer's Type MedDRA version: 20.0 Level: PT Classification code 10001497 Term: Agitation System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: AVP-786 (deudextromethorphan hydrobromide/quinidine sulphate)
Product Code: AVP-786
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Quinidine Sulfate
CAS Number: 6591-63-5
Curren
Sponsors
Avanir Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of probable AD according to the 2011 NIA-AA working groups criteria. 2. The patient has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization. 3. The diagnosis of agitation must meet the IPA provisional definition of agitation. 4. CGIS-Agitation score is = 4 (moderately ill) at Screening and Baseline. 5. MMSE score between 6 and 26 (inclusive) at Screening and Baseline. 6. Caregiver must be willing and able to comply with study procedures,including not administering any prohibited medications during the course of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 103 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 309
Exclusion criteria
Exclusion criteria: 1. Patient has dementia predominantly of non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia). 2. Patients with symptoms of agitation that are not secondary to AD (e.g., secondary to pain, other psychiatric disorder, or delirium). 3. Patients with myasthenia gravis (contraindication for quinidine).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type;Secondary Objective: None;Primary end point(s): Change from Baseline to Week 12 in the composite Cohen-Mansfield Agitation Inventory (CMAI) scores;Timepoint(s) of evaluation of this end point: The CMAI will be assessed at Screening (Day -28 to Day -1), Baseline (Day 1), Day 8 (Visit 2), Day 15 (Visit 2.1), Day 22 (Visit 3), Day 43 (Visit 4), Day 64 (Visit 5), Day 85 (Visit 6), and Follow up visit (for ET patients). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from Baseline to Week 12 (Day 85) in the following measures: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC)-Agitation Neuropsychiatric Inventory (NPI) Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Patient Global Impression of Change (PGIC) Dementia Quality of Life (DEMQOL) Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Resource Utilization in Dementia (RUD) EuroQol 5-Dimension 5-Level (EQ-5D-5L);Timepoint(s) of evaluation of this end point: mADCS-CGIC-Agitation:Day(d) 1,d43(Visit(v) 4),d85(v6 /ET), and Follow-up visit (for ET patients);NPI-Agitation/Aggression domain score and CaregiverDistress score:Screening (d-28 to d-1),d8 (v2), and d15(v2.1); NPI-AberrantMotorBehaviordomain: (d1), d22(v3),d43(v4),d64(v5),and d85(v6/ET); NPI-Irritability/Lability domain:(d1),d22 (v3),d43 (v4),d64(v5),and d85(v6/ET);Total NPI:(d1), d22(v3),d4(v4),d6 (v5),and d85(v6/ET);CGIS-Agitation: Screening (d-28 to d-1),(d1),d43(v4) ,and d85 (v6/ET);ADCS-CGIC-Overall:(d1),d85(v6/ET);PGIC: d43(v4) and d85(v6/ET); DEMQOL:(d1), d43 (v4),and d85(v6/ET) for patients withMMSE =10 at the d1;EQ-5D-5L: (d1),d43 (v4),and d85(v6/ET)for patients with MMSE =10;ADAS-cog:(d1)and d85(v6/ET) forpatients withanMMSEscoreof= 10 at the d1visit;RUD:(d1),d43 (v4),d85(v6/ET) | — |
Countries
Australia, Bulgaria, Czech Republic, France, Germany, Hungary, Italy, Poland, South Africa, Spain, United Kingdom
Contacts
Public ContactAgitation Project Team
Avanir Pharmaceuticals Inc.
Outcome results
None listed