Alzheimer's MedDRA version: 20.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: ANAVEX2-73
Product Code: ANAVEX2-73
Pharmaceutical Form: Capsule
INN or Proposed INN: ANAVEX2-73
Current Sponsor code: ANAVEX2-73
Other descriptive name: ANA001xHCl (Syntagon) or VEXA-04
Sponsors
Anavex Germany GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Previous completion of participation in the ANAVEX2-73-AD-004 double-blind study. 2. Participants may be either outpatients, or residents of an assisted-living facility. 3. Participants must have a designated study partner, who spends at least 10 hr per week with the participant, in order for assessments (e.g., carer burden instruments) to be completed with sufficient knowledge of the participant. 4. No suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (CSSRS) in the past 3 months (i.e., active suicidal thought(s) with intent but without specific plan, or active suicidal thought(s) with plan and intent) OR suicidal behavior in the past 2 years (i.e., actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior). 5. Confirmation from the participant that, if of childbearing potential, is not pregnant through urine pregnancy testing. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 325
Exclusion criteria
Exclusion criteria: 1. Adverse events (AEs) from the previous study (ANAVEX2-73-AD-004) that have not resolved, are moderate or severe, judged to be possibly related or related to study drug, and considered by the investigator to be a contraindication to extension study participation. 2. Any condition or laboratory abnormality that would make the subject, in the judgment of the investigator, unsuitable for the study. 3. Significant history of drug addiction (with the exception of nicotine dependence) or abuse (including alcohol, as defined in DSM-5 or in the opinion of the investigator) within the last two years prior to informed consent, or a positive urine drug screen for cocaine, opioid, phencyclidine (PCP), amphetamine or marijuana at baseline. Prescription medication yielding a positive drug screen are acceptable except for tricyclic antidepressants. 4. Any known hypersensitivity to any of the excipients contained in the study drug formulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To continue assessing the safety and tolerability of ANAVEX2-73;Secondary Objective: Secondary outcome measures include refined measures of cognition, sleep, behavioural and psychological symptoms typically observed in AD, changes in daily functioning of participants, and changes in caregiver burden, as well as changes in quality of life measures of both patients and caregivers during treatment with ANAVEX2-73.;Primary end point(s): Safety Assessments will occur at all study visits, and at any other time if medically indicated. Safety assessments will include the following: 1. Physical and neurological examination 2. Vital signs (heart rate, respiratory rate, systolic blood pressure [SBP], diastolic blood pressure [DBP], and oral body temperature) 3. Graded Adverse Events (AEs) according to common Terminology Criteria for Adverse Events (CTCAE) V4.0.3 4. 12-lead ECG 5. Clinical laboratory tests (hematology, coagulation, clinical chemistry, and urinalysis) 6. Columbia-Suicide Severity Rating Scale (C-SSRS);Timepoint(s) of evaluation of this end point: 96 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from baseline to week 96 in cognition according to the Alzheimer Disease Assessment Scale-Cognition (ADAS-Cog) 2. Change from baseline to week 96 in ability to perform daily activities according to the Alzheimer’s Disease Cooperative Study-Activities of Daily Living Scale (ADCS-ADL) 3. Change from baseline to week 96 in dementia symptom severity according to the Mini-Mental-State Examination (MMSE) 4. Change from baseline to week 96 in the Neuropsychiatric Inventory Questionnaire (NPI-Q) 5. Change from baseline to week 96 in the level of burden experienced by caregivers according to the Zarit Burden Interview (ZBI) 6. Change from baseline to week 96 in the level of quality of life experienced by patient and caregiver according to the Quality of Life of Alzheimer’s Disease Patient and Caregiver Report (QoL-AD) 7. Observation of P-tau blood level concentration;Timepoint(s) of evaluation of this end point: 96 Weeks | — |
Countries
Australia, Canada, Germany, Netherlands
Contacts
Public ContactShari Coslett
Anavex
Outcome results
None listed