Alzheimer's Disease
Conditions
Keywords
Alzheimer's disease, cognition global functioning, symptomatic, B-742457
Brief summary
The purpose of this study is to find out if SB-742457 is a safe treatment and what effects it has on the symptoms of mild to moderate Alzheimer's disease. SB-742457 is a new treatment which is thought to increase the levels of certain chemicals in the brain that are often decreased in patients with Alzheimer's disease.
Interventions
DRUGSB-742457
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of probable mild-to-moderate Alzheimer's disease as determined by the NINCDS-ADRDA and DSM-IV criteria with an MMSE score of 12-24. * Subjects and their caregivers must provide informed consent prior to study entry. * Adequate blood pressure and laboratory values.
Exclusion criteria
* Females of child-bearing potential. * Have other causes of dementia such as vascular damage, depression, bipolar affective disorder, schizophrenia, syphilis, vitamin B12 deficiency or thyroid deficiency. * Subjects taking medication for Alzheimer's disease or centrally acting agents which might impact study outcomes. * Subjects taking agents for which there is a theoretical risk of interaction with SB-742457. * Subjects with known hypersensitivity to sunlight or seizures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in cognition and function after 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in behavioural symptoms, activities of daily living and caregiver burden after 24 weeks. Changes in all symptoms at 8 and 12 weeks. Safety and tolerability. PK and dose response profiling. Efficacy related to ApoE status. | — |
Countries
Austria, Bulgaria, Chile, Croatia, Czechia, Greece, New Zealand, Poland, Russia, Slovakia, South Africa, South Korea, Spain
Outcome results
None listed