Dual vs Mono therapy.
I am confused. Here is the only on-going trial for Anavex 2-73 copied from clinicaltrials.gov. Maybe I don't understand the argument about dual therapy.
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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
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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
This was filed March 8,2016 and it shows Anavex 2-73 as the only drug administered.
