Alzheimer's disease is the most common form of dementia and is the fourth leading cause of death among people 65 years of age and older. The global prevalence of the disease will increase significantly as the population ages, unless preventative treatments can be identified and marketed. The present study seeks to evaluate AZD3480 (TC-1734) compared to an approved medication (donepezil) shown to improve cognition and function in patients with Alzheimer's disease.
This is a double blind, positive comparator, randomized, multicenter, parallel group study to assess the efficacy, safety, and tolerability of AZD3480 as monotherapy in patients with mild to moderate dementia of the Alzheimer's type (AD). Approximately 300 subjects will be randomized and divided into 2 cohorts. Actual randomization was 293 subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
386
Change from baseline in the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog)
Time frame: 52 weeks
Change from baseline in the Clinician Interview-Based Impression of Change plus carer interview [CIBIC-(+)]
The CIBIC-(+) is a co-primary endpoint with the ADAS-Cog in the United States.
Time frame: 52 Weeks
Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
The ADCS-ADL is the co-primary endpoint with the ADAS-Cog in Europe.
Time frame: 52 Weeks
Change from baseline in the Neuropsychiatric Inventory (NPI)
Time frame: 52 Weeks
Change from baseline in the Mini-Mental State Examination (MMSE)
Time frame: 52 Weeks
Change from baseline in the Alzheimer's Disease Related Quality of Life (ADRQL)
Time frame: 52 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Banner Alzheimer Institute
Phoenix, Arizona, United States
Meridien Research
Brooksville, Florida, United States
MD Clinical
Hallandale, Florida, United States
Policlinic
Choceň, Czechia
BRAIN-SOULTHERAPY s.r.o.
Kladno, Czechia
Bialbi.s.r.o. Psychiatrické oddělení
Litoměřice, Czechia
Psychiatricka Ambulance
Olomouc, Czechia
Vojenska Nemocnice Psychiatricke oddeleni
Olomouc, Czechia
Clintrial
Prague, Czechia
PRAGTIS s.r.o.
Prague, Czechia
...and 23 more locations