The primary purpose of the study is to determine the safety and tolerability of AZD1446 vs Placebo given as an add-on treatment to Donepezil for 4 weeks in patients with mild to moderate Alzheimer's disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
99
Research Site
Litoměřice, Czechia
Research Site
Prague, Czechia
Research Site
Praha 10 - Strasnice, Czechia
Research Site
Debrecen, Hungary
Nature and incidence of adverse events
Time frame: From the enrollment visit until the last study follow-up visit. The measure will be taken at each scheduled study visit and in between visits , if any adverse events occur.
To evaluate any effects PK of AZD1446 as an add-on treatment to donepezil on the PK of donepezil
Time frame: Twice during the study: at Visit 2 and Visit 10.
To characterize the PK of AZD1446 as an add-on treatment to donepezil in AD patients
Time frame: Twice during the study: at Visit 8 and Visit 10.
To explore the effects of 3 dose regimens of AZD1446 compared to placebo as an add-on treatment to donepezil on changes in global functioning using ADCS-CGIC
Time frame: Baseline assessment at Visit 2 and a follow-up assessment at Visit 10
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Research Site
Esztergom, Hungary
Research Site
Miskolc, Hungary
Research Site
Nagykálló, Hungary
Research Site
Nyíregyháza, Hungary
Research Site
Szeged, Hungary
Research Site
Bratislava, Slovakia
...and 2 more locations