Last updated: 11/04/2018 05:24:16
SB-742457 And Donepezil In Alzheimer’s Disease
GSK study ID
AZ3106242
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Double-Blind, Randomised, Placebo-Controlled, Parallel Group Study to Investigate the Effects of SB-742457, Donepezil and Placebo on Cognition in Subjects with Mild to Moderate Alzheimer’s Disease
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: SB-742457
Drug: donepezil
Enrollment:
200
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Alzheimer's Disease
Product
SB742457
Collaborators
Not applicable
Study date(s)
May 2006 to June 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
50 - 85 Years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion criteria
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 Alzheimers 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 or donepezil.
- Subjects with conditions which might be exacerbated by exposure to donepezil.
- Subjects with known hypersensitivity to sunlight or seizures.
Trial location(s)
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7560356
Status
Study Complete
Location
GSK Investigational Site
Valparaiso, Valparaíso, Chile, 2352499
Status
Study Complete
Location
GSK Investigational Site
Providencia / Santiago, Región Metro De Santiago, Chile, 7500710
Status
Study Complete
Location
GSK Investigational Site
Baesweiler, Nordrhein-Westfalen, Germany, 52499
Status
Study Complete
Location
GSK Investigational Site
West of Scotland Science Park, Glasgow, United Kingdom, G20 0XA
Status
Study Complete
Location
GSK Investigational Site
Hattingen, Nordrhein-Westfalen, Germany, 45525
Status
Study Complete
Location
GSK Investigational Site
Ostfildern, Baden-Wuerttemberg, Germany, 73760
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-12-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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