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Trial details imported from ClinicalTrials.gov

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




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

Titles & IDs
Public title
OLE for Patients Enrolled in 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 - To continue assessing the safety and tolerability of ANAVEX2-73
Timepoint [1] 0 0
96 weeks
Secondary outcome [1] 0 0
ADAS-Cog (Alzheimer Disease Assessment Scale-Cognition) - Change from baseline to week 96 in cognition according to the Alzheimer Disease Assessment Scale-Cognition (ADAS-Cog)
Timepoint [1] 0 0
96 weeks
Secondary outcome [2] 0 0
ADCS-ADL (Activities of Daily Living) - 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)
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
Gender
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
N/A
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/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NEWQLD,SA,VIC
Recruitment hospital [1] 0 0
Sydney - Hornsby
Recruitment hospital [2] 0 0
Sydney - Macquarie Park
Recruitment hospital [3] 0 0
Sydney - Sydney
Recruitment hospital [4] 0 0
Gold Coast - Gold Coast
Recruitment hospital [5] 0 0
Adelaide - Adelaide
Recruitment hospital [6] 0 0
Melbourne - Belmont
Recruitment hospital [7] 0 0
Melbourne - Malvern
Recruitment hospital [8] 0 0
Melbourne - Melbourne N.
Recruitment hospital [9] 0 0
Melbourne - Melbourne
Recruitment hospital [10] 0 0
Melbourne - Delmont
Recruitment hospital [11] 0 0
Melbourne - Melbourne E.
Recruitment postcode(s) [1] 0 0
- Hornsby
Recruitment postcode(s) [2] 0 0
- Macquarie Park
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment postcode(s) [4] 0 0
- Gold Coast
Recruitment postcode(s) [5] 0 0
- Adelaide
Recruitment postcode(s) [6] 0 0
- Belmont
Recruitment postcode(s) [7] 0 0
- Malvern
Recruitment postcode(s) [8] 0 0
- Melbourne N.
Recruitment postcode(s) [9] 0 0
- Melbourne
Recruitment postcode(s) [10] 0 0
- Delmont
Recruitment postcode(s) [11] 0 0
- Melbourne E.

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

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04314934
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
Study Director
Address 0 0
Country 0 0
Phone 0 0
844-689-3939
Fax 0 0
Email 0 0
alz@anavex.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04314934