The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02756858




Registration number
NCT02756858
Ethics application status
Date submitted
8/03/2016
Date registered
29/04/2016
Date last updated
19/11/2019

Titles & IDs
Public title
An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease
Scientific title
An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease
Secondary ID [1] 0 0
ANAVEX2-73-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's 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: ANAVEX2-73 Oral as assigned in ANAVEX2-73-002 -


Treatment: Drugs: ANAVEX2-73


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 v4.0 - Safety
Timepoint [1] 0 0
Up to 208 weeks
Secondary outcome [1] 0 0
Score from MMSE (Mini-mental state examination score) - Exploratory Efficacy
Timepoint [1] 0 0
Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208
Secondary outcome [2] 0 0
Score from ADCS-ADL (Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory) - Exploratory Efficacy
Timepoint [2] 0 0
Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208
Secondary outcome [3] 0 0
HAM-D Score (Hamilton Psychiatric Rating Scale for Depression) - Exploratory Efficacy
Timepoint [3] 0 0
Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208

Eligibility
Key inclusion criteria
- Previous exposure to ANAVEX2-73 via participation in Phase 2a Study of ANAVEX2-73
Adaptive-Trial-Design With Repeated Doses, MTD Finding, Pharmacodynamic and
Bioavailability Evaluation in Patients With Mild to Moderate Alzheimer's Disease With
a 12-Month Open Label Follow-Up Period (ANAVEX2-73-002)
Minimum age
55 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Have not previously participated Phase 2a Study of ANAVEX2-73 Adaptive-Trial-Design
With Repeated Doses, MTD Finding, Pharmacodynamic and Bioavailability Evaluation in
Patients With Mild to Moderate Alzheimer's Disease With a 12-Month Open Label
Follow-Up Period (ANAVEX2-73-002)

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
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not 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)
VIC
Recruitment hospital [1] 0 0
Melbourne Health - The Royal Melbourne Hospital - Melbourne
Recruitment hospital [2] 0 0
Austin Health - Heidelberg Repatriation Hospital - Melbourne
Recruitment hospital [3] 0 0
Caulfield Hospital - Melbourne
Recruitment hospital [4] 0 0
Nucleus Network- Centre for Clinical Studies - Melbourne
Recruitment hospital [5] 0 0
St. Vincent's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne
Recruitment postcode(s) [2] 0 0
3084 - Melbourne
Recruitment postcode(s) [3] 0 0
3162 - Melbourne
Recruitment postcode(s) [4] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Anavex Life Sciences Corp.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This open label extension study is designed to provide continued access to ANAVEX 2-73 for
eligible subjects with mild to moderate Alzheimer's Disease who have previously participated
in the Anavex sponsored study ANAVEX2-73-002.
Trial website
https://clinicaltrials.gov/show/NCT02756858
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

Summary results
Other publications