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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04314934




Registration number
NCT04314934
Ethics application status
Date submitted
12/12/2019
Date registered
19/03/2020

Titles & IDs
Public title
OLE of Phase 2b/3 Study ANAVEX2-73-AD-004
Scientific title
Open Label Extension Study for Patients With Early Alzheimer's Disease (AD) Enrolled in Study ANAVEX2-73-AD-004
Secondary ID [1] 0 0
ANAVEX2-73-AD-EP-004
Universal Trial Number (UTN)
Trial acronym
ATTENTION-AD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ANAVEX2-73

Experimental: Active - ANAVEX2-73


Treatment: Drugs: ANAVEX2-73
Oral capsules
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Timepoint [1] 0 0
96 weeks
Secondary outcome [1] 0 0
ADAS-Cog (Alzheimer Disease Assessment Scale-Cognition)
Timepoint [1] 0 0
96 weeks
Secondary outcome [2] 0 0
ADCS-ADL (Activities of Daily Living)
Timepoint [2] 0 0
96 weeks

Eligibility
Key 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.
Minimum age
55 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/06/2024
Sample size
Target
Accrual to date
Final
300
Recruitment in Australia
Recruitment state(s)
NSW,NEWQLD,QuennslandSA,VIC,WA
Recruitment hospital [1] 0 0
Central Coast Neurosciences Research - Central Coast
Recruitment hospital [2] 0 0
Hornsby (Northern Sydney Health) - Hornsby
Recruitment hospital [3] 0 0
Sydney - Hornsby
Recruitment hospital [4] 0 0
KaRa MINDS - Macquarie Park
Recruitment hospital [5] 0 0
Sydney - Macquarie Park
Recruitment hospital [6] 0 0
Sydney - Sydney
Recruitment hospital [7] 0 0
University of Sydney - Sydney
Recruitment hospital [8] 0 0
Gold Coast - Gold Coast
Recruitment hospital [9] 0 0
Gold Coast Memory Disorders Clinic - Southport
Recruitment hospital [10] 0 0
Adelaide - Adelaide
Recruitment hospital [11] 0 0
Melbourne - Belmont
Recruitment hospital [12] 0 0
Geelong Private Medical Centre - Geelong
Recruitment hospital [13] 0 0
Delmont Private Hospital - Glen Iris
Recruitment hospital [14] 0 0
Hammond Care - Malvern
Recruitment hospital [15] 0 0
Melbourne - Malvern
Recruitment hospital [16] 0 0
Melbourne - Melbourne N.
Recruitment hospital [17] 0 0
Austin Health - Melbourne
Recruitment hospital [18] 0 0
Melbourne - Melbourne
Recruitment hospital [19] 0 0
McCusker - Nedlands
Recruitment hospital [20] 0 0
Melbourne - Delmont
Recruitment hospital [21] 0 0
Hammond Health - Malvern
Recruitment hospital [22] 0 0
Melbourne - Melbourne E.
Recruitment postcode(s) [1] 0 0
- Central Coast
Recruitment postcode(s) [2] 0 0
- Hornsby
Recruitment postcode(s) [3] 0 0
- Macquarie Park
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment postcode(s) [5] 0 0
- Gold Coast
Recruitment postcode(s) [6] 0 0
- Southport
Recruitment postcode(s) [7] 0 0
- Adelaide
Recruitment postcode(s) [8] 0 0
- Belmont
Recruitment postcode(s) [9] 0 0
- Geelong
Recruitment postcode(s) [10] 0 0
- Glen Iris
Recruitment postcode(s) [11] 0 0
- Malvern
Recruitment postcode(s) [12] 0 0
- Melbourne N.
Recruitment postcode(s) [13] 0 0
- Melbourne
Recruitment postcode(s) [14] 0 0
- Nedlands
Recruitment postcode(s) [15] 0 0
- Delmont
Recruitment postcode(s) [16] 0 0
- Melbourne E.
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Germany
State/province [3] 0 0
Baden-Wuerttemberg
Country [4] 0 0
Germany
State/province [4] 0 0
Bavaria
Country [5] 0 0
Germany
State/province [5] 0 0
Hessen
Country [6] 0 0
Germany
State/province [6] 0 0
Lower Saxony
Country [7] 0 0
Germany
State/province [7] 0 0
North Rhine-Westphalia
Country [8] 0 0
Germany
State/province [8] 0 0
Rheinland-Pfalz
Country [9] 0 0
Germany
State/province [9] 0 0
Berlin
Country [10] 0 0
Netherlands
State/province [10] 0 0
Amsterdam
Country [11] 0 0
Netherlands
State/province [11] 0 0
Den Bosch
Country [12] 0 0
Netherlands
State/province [12] 0 0
Zwolle
Country [13] 0 0
United Kingdom
State/province [13] 0 0
County Teesside
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Scotland
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Surrey
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Barnsley
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Blackpool
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Cannock
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Leeds
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Liverpool
Country [21] 0 0
United Kingdom
State/province [21] 0 0
London
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Manchester
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Anavex Life Sciences Corp.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Anavex Australia Pty Ltd.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Anavex Germany GmbH
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04314934