Clinical trial NCT04314934: OLE of Phase 2b/3 Study ANAVEX2-73-AD-004
Official title: Open Label Extension Study for Patients With Early Alzheimer's Disease (AD) Enrolled in Study ANAVEX2-73-AD-004
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Alzheimer Disease
Lead sponsor: Anavex Life Sciences Corp.
Sponsor class: INDUSTRY
Collaborators: name: Anavex Australia Pty Ltd.
name: Anavex Germany GmbH
First posted: 2020-03-19
Enrollment: 300
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 2b/3 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and effficacy of daily treatment.

Detailed description: This is a Phase 2b/3 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and effficacy of daily treatment.

Eligibility criteria: Inclusion Criteria:

* Previous completion of participation in the ANAVEX2-73-AD-004 double-blind study.
* Participants may be either outpatients, or residents of an assisted-living facility.
* Participants must have a designated study partner, who spends at least 10hrs per week with the participant, in order that assessments e.g. carer burden instruments are completed with true knowledge of the participant.
* No suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (C-SSRS) 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).
* Confirmation from the participant that, if of childbearing potential is not pregnant through urine pregnancy testing.

Exclusion Criteria:

* 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
* Any condition or laboratory abnormality that would make the subject, in the judgment of the investigator, unsuitable for the study
* Significant history of drug addiction (with the exception of nicotine dependence) or abuse (including alcohol, as defined in DSM-V 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 screening. Prescription medication yielding a positive drug screen are acceptable except for tricyclic antidepressants (e.g. Amitriptyline, Amoxapine, Desipramine, (Norpramin) Doxepin, Imipramine (Tofranil), Nortriptyline (Pamelor), Protriptyline (Vivactil), Trimipramine (Surmontil)).
* Any known hypersensitivity to any of the excipients contained in the study drug formulation.

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
timeFrame: 96 weeks
Secondary outcomes:
measure: ADAS-Cog (Alzheimer Disease Assessment Scale-Cognition)
timeFrame: 96 weeks
measure: ADCS-ADL (Activities of Daily Living)
timeFrame: 96 weeks
Other outcomes:
Locations:
city: Central Coast
country: Australia
facility: Central Coast Neurosciences Research
state: New South Wales
city: Hornsby
country: Australia
facility: Hornsby (Northern Sydney Health)
state: New South Wales
city: Hornsby
country: Australia
facility: Sydney
state: New South Wales
city: Macquarie Park
country: Australia
facility: KaRa MINDS
state: New South Wales
city: Macquarie Park
country: Australia
facility: Sydney
state: New South Wales
city: Sydney
country: Australia
facility: Sydney
state: New South Wales
city: Sydney
country: Australia
facility: University of Sydney
state: New South Wales
city: Sydney
country: Australia
facility: Sydney
state: NEW
city: Gold Coast
country: Australia
facility: Gold Coast
state: Queensland
city: Southport
country: Australia
facility: Gold Coast Memory Disorders Clinic
state: Quennsland
city: Adelaide
country: Australia
facility: Adelaide
state: South Australia
city: Belmont
country: Australia
facility: Melbourne
state: Victoria
city: Geelong
country: Australia
facility: Geelong Private Medical Centre
state: Victoria
city: Glen Iris
country: Australia
facility: Delmont Private Hospital
state: Victoria
city: Malvern
country: Australia
facility: Hammond Care
state: Victoria
city: Malvern
country: Australia
facility: Melbourne
state: Victoria
city: Melbourne N.
country: Australia
facility: Melbourne
state: Victoria
city: Melbourne
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: Melbourne
state: Victoria
city: Nedlands
country: Australia
facility: McCusker
state: Western Australia
city: Delmont
country: Australia
facility: Melbourne
city: Malvern
country: Australia
facility: Hammond Health
city: Melbourne E.
country: Australia
facility: Melbourne
city: Calgary
country: Canada
facility: Healthy Brain Aging Labs Uni of Calgary
state: Alberta
city: Ottawa
country: Canada
facility: Bruyere Continuing Care
state: Ontario
city: Peterborough
country: Canada
facility: Kawartha Centre
state: Ontario
city: Toronto
country: Canada
facility: Bay Crest Health Sciences
state: Ontario
city: Toronto
country: Canada
facility: Toronto Memory Program
state: Ontario
city: Ulm
country: Germany
facility: University of Ulm, Memory Clinic
state: Baden-Wuerttemberg
city: Bayreuth
country: Germany
facility: Bayreuth Clinic, Hohe Warte Hospital
state: Bavaria
city: München
country: Germany
facility: Technical University of Munich, School of Medicine
state: Bavaria
city: Mannheim
country: Germany
facility: Central Institute of Mental Health
state: Hessen
city: Goettingen
country: Germany
facility: Goettingen University Medicine, Clinic for Psychiatry and Psychotherapy
state: Lower Saxony
city: Bonn
country: Germany
facility: University Hospital, Bonn
state: North Rhine-Westphalia
city: Mainz
country: Germany
facility: Clinic for Psychiatry and Psychotherapy
state: Rheinland-Pfalz
city: Berlin
country: Germany
facility: Charite University Medicine
city: Amsterdam
country: Netherlands
facility: Brain Research Center
city: Den Bosch
country: Netherlands
facility: Brain Research Center
city: Zwolle
country: Netherlands
facility: Brain Research Center
city: Teesside
country: United Kingdom
facility: MAC Clinical Research
state: County Teesside
city: Glasgow
country: United Kingdom
facility: Glasgow Memory Clinic
state: Scotland
city: Guildford
country: United Kingdom
facility: Cognition Health
state: Surrey
city: Barnsley
country: United Kingdom
facility: MAC Clinical Research
city: Blackpool
country: United Kingdom
facility: MAC Clinical Research
city: Cannock
country: United Kingdom
facility: MAC Clinical Research
city: Leeds
country: United Kingdom
facility: MAC Clinical Research
city: Liverpool
country: United Kingdom
facility: MAC Clinical Research
city: London
country: United Kingdom
facility: Cognition Health
city: London
country: United Kingdom
facility: Imperial College
city: Manchester
country: United Kingdom
facility: MAC Clinical Research
city: Plymouth
country: United Kingdom
facility: Cognition Health
Study officials:
References: