Phase 2b/3 48-week study to evaluate the effects of ANAVEX2-73 on cognition and function after 48 weeks of daily treatment. Additional outcome measures include refined measures of sleep, behavioral and psychological symptoms typically observed in AD, changes in daily functioning of participants and changes in caregiver burden, as well as changes in quality of life measures of both, patients and caregivers during treatment with ANAVEX2-73.
This is a Phase 2b/3 48-week study to evaluate the effects of ANAVEX2-73 on cognition and function after 48 weeks of daily treatment. Additional outcome measures include refined measures of sleep, behavioral and psychological symptoms typically observed in AD, changes in daily functioning of participants and changes in caregiver burden, as well as changes in quality of life measures of both, patients and caregivers during treatment with ANAVEX2-73. In addition, safety assessments, pharmacokinetic (PK) assessments and collections of CSF and blood markers of AD pathophysiology before and after treatment will be performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
509
Oral capsule
Oral capsule
Oral capsule
ADAS-Cog (Alzheimer Disease Assessment Scale-Cognition)
Reduction in cognitive decline assessed from baseline over 48 weeks with ANAVEX2-73 compared to placebo using the Alzheimer Disease Assessment Scale-Cognition (ADAS-Cog)
Time frame: 48 weeks
ADCS-ADL (Activities of Daily Living)
Reduction in decline of the ability to perform daily activities assessed from baseline over 48 weeks with ANAVEX2-73 compared to placebo using the Activities of Daily Living Scale (ADCS-ADL)
Time frame: 48 weeks
CDR-SB (Clinical Dementia Rating Scale Sum of Boxes)
Reduction in cognitive decline assessed from baseline over 48 weeks with ANAVEX2-73 compared with placebo using the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)
Time frame: 48 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Assess the safety and tolerability of ANAVEX2-73 compared to placebo
Time frame: 48 weeks
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Central Coast Neurosciences Research
Central Coast, New South Wales, Australia
Hornsby (Northern Sydney Health)
Hornsby, New South Wales, Australia
KaRa MINDS
Macquarie Park, New South Wales, Australia
St Vincent Hospital Sydney
Sydney, New South Wales, Australia
University of Sydney
Sydney, New South Wales, Australia
Gold Coast Memory Disorders Clinic
Southport, Quennsland, Australia
The Royal Adelaide Hospital (RAH) and The Queen Elizabeth Hospital (TQEH)
Adelaide, South Australia, Australia
Penninsula Therapeutic and Research Group
Frankston, Victoria, Australia
Geelong Private Medical Centre
Geelong, Victoria, Australia
Delmont Private Hospital
Glen Iris, Victoria, Australia
...and 44 more locations