The primary objective of the study is to investigate the effects of oral TRx0014 at three doses (30, 60 and 100 mg tid) compared with placebo on cognitive ability in patients with mild or moderate dementia of the Alzheimer type. Cognitive ability will be measured by the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog). The primary evaluation will be made at 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
323
Cognitive ability (ADAS-cog)
Time frame: At 24 weeks
Behavioural and psychological symptoms (NPI)
Time frame: At 12 and 24 weeks
Global performance (ADCS-CGIC)
Time frame: At 12 and 24 weeks
Dementia severity (CDR-sb)
Time frame: At 12 and 24 weeks
Cognition (MMSE)
Time frame: At 12 and 24 weeks
Dementia caseness (Short CAMDEX)
Time frame: At 12 and 24 weeks
Cognitive function (ADAS-cog)
Time frame: At 6, 12, 18 and 24 weeks
Daily activities of living (BADLS)
Time frame: At 12 and 24 weeks
Changes in cerebral perfusion pattern (SPECT or PET)
Time frame: At baseline and between 24-26 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hard capsule, 100 milligrams, t.i.d.