Blu 1 - Not true. I believe you are referring to the original study NCT02244541.
The current study NCT02756858 does not mention comparing to "add-on".
ClinicalTrials.gov
Phase 2a Dose Finding, PK/PD and 12 Month Exploratory Efficacy Study of ANAVEX2-73 in Patients With Alzheimer's Disease (ANAVEX)
This study is ongoing, but not recruiting participants.
Sponsor:
Anavex Life Sciences Corp.
Information provided by (Responsible Party):
Anavex Life Sciences Corp.
ClinicalTrials.gov Identifier:
NCT02244541
First received: August 31, 2014
Last updated: August 10, 2016
Last verified: August 2016
History of Changes
Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
Purpose
The primary objective of this Phase 2a study is to evaluate the maximal tolerated dose of ANAVEX2-73 in patients with AD in a repeated-dose administration scheme, with the secondary objectives being to explore the relationship between dosing regimen and pharmacodynamics efficacy outcomes and to evaluate the bioavailability of the oral form used and to explore the relationship of ANAVEX2-73 as add-on therapy to AD standard of care.
Condition Intervention Phase
Alzheimer's Disease
Drug: ANAVEX2-73 Oral
Drug: ANAVEX2-73 Intravenous
Phase 2
Here is the current study that indicates Anavex 2-73 oral only.
ClinicalTrials.gov
A service of the U.S. National Institutes of Health
An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease
This study is enrolling participants by invitation only.
Sponsor:
Anavex Life Sciences Corp.
Information provided by (Responsible Party):
Anavex Life Sciences Corp.
ClinicalTrials.gov Identifier:
NCT02756858
First received: March 8, 2016
Last updated: April 27, 2016
Last verified: April 2016
History of Changes
Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
Purpose
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.
Condition Intervention Phase
Alzheimer's Disease
Drug: ANAVEX2-73
Phase 2
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease
Resource links provided by NLM:
Genetics Home Reference related topics: Alzheimer disease
MedlinePlus related topics: Alzheimer's Disease
Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease
U.S. FDA Resources
Further study details as provided by Anavex Life Sciences Corp.:
Primary Outcome Measures:
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 104 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
Mini-mental state examination score (MMSE) [ Time Frame: Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, & 104 ] [ Designated as safety issue: No ]
Score from ADCS-ADL (Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory) [ Time Frame: Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, & 104 ] [ Designated as safety issue: No ]
Hamilton Psychiatric Rating Scale for Depression (HAM-D) Score [ Time Frame: Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, & 104 ] [ Designated as safety issue: No ]
Estimated Enrollment: 32
Study Start Date: March 2016
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ANAVEX2-73 Oral as assigned in ANAVEX2-73-002 Drug: ANAVEX2-73
Eligibility
Ages Eligible for Study: 55 Years to 85 Years (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
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)
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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