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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02756858
Registration number
NCT02756858
Ethics application status
Date submitted
8/03/2016
Date registered
29/04/2016
Date last updated
12/01/2021
Titles & IDs
Public title
An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease
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Scientific title
An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease
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Secondary ID [1]
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ANAVEX2-73-003
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease
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Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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Dementias
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ANAVEX2-73
Experimental: ANAVEX2-73 Oral as assigned in ANAVEX2-73-002 -
Treatment: Drugs: ANAVEX2-73
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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Assessment method [1]
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Safety
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Timepoint [1]
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Up to 208 weeks
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Secondary outcome [1]
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Score from MMSE (Mini-mental state examination score)
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Assessment method [1]
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Exploratory Efficacy
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Timepoint [1]
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Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208
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Secondary outcome [2]
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Score from ADCS-ADL (Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory)
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Assessment method [2]
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Exploratory Efficacy
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Timepoint [2]
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Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208
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Secondary outcome [3]
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HAM-D Score (Hamilton Psychiatric Rating Scale for Depression)
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Assessment method [3]
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Exploratory Efficacy
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Timepoint [3]
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Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208
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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)
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Minimum age
55
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2020
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Sample size
Target
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Accrual to date
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Final
21
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Melbourne Health - The Royal Melbourne Hospital - Melbourne
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Recruitment hospital [2]
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Austin Health - Heidelberg Repatriation Hospital - Melbourne
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Recruitment hospital [3]
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Caulfield Hospital - Melbourne
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Recruitment hospital [4]
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Nucleus Network- Centre for Clinical Studies - Melbourne
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Recruitment hospital [5]
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St. Vincent's Hospital - Melbourne
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Recruitment postcode(s) [1]
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3050 - Melbourne
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Recruitment postcode(s) [2]
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3084 - Melbourne
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Recruitment postcode(s) [3]
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3162 - Melbourne
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Recruitment postcode(s) [4]
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- Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Anavex Life Sciences Corp.
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02756858
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02756858
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