Alzheimer's Disease MedDRA version: 9.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease
Conditions
Interventions
Product Name: GSK239512
Product Code: GSK239512
Pharmaceutical Form: Tablet
Current Sponsor code: GSK239512
Concentration unit: µg micro
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects with a clinical diagnosis of probable Alzheimer’s disease in accordance with the NINCDS-ADRDA criteria. 2. A Haschinski ischaemia score 40 MlU/ml and estradiol 1.5xULN is acceptable if bilirubin is fractionated and di
Exclusion criteria
Exclusion criteria: 1. In the opinion of the investigator, following review of CT/MRI scans in the past 12 months and completion of neurological review there could be other probable causes of dementia 2. Prior diagnosis of significant psychiatric illness (with current symptoms related to the diagnoses such that in the opinion of the Investigator would interfere with participation in the study), or current depression, or subjects with other psychiatric features in their AD which in the opinion of the investigator, increase risk to safety. 3.Subject has made a suicide attempt within the 6 months preceeding the screening visit or presents with suicidal ideation of type 4 or type 5 on the C-SSRS at the Screen or Baseline visits. 4. History of significant sleep disturbance which in the opinion of the investigator, may increase safety risk. 5. History or presence of known or suspected seizures, unexplained significant loss of consciousness within last 6 months. Subjects who had febrile seizures in childhood may be included if these ceased by age 10 and they have had no other type of seizure in their medical history and have not been on anti-epileptic medications. 6. History or presence of significant CV, GI, hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs, or any other clinically relevant abnormality, medical or psychiatric condition, which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study. 7. History of alcohol or other substance abuse according to DSM-IV criteria. 8. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening 9. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). 10. Uncontrolled hypertension with systolic BP =160 and/or diastolic =95 mmHg. Subjects with controlled hypertension with systolic BP 450ms or >480ms if they have bundle branch block or other ECG abnormalities which, in the opinion of the investigator is clinically significant in that they may increase safety risk. 13. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). 14. Exposure to more than four new chemical entities within 12 months prior to the first dosing day. 15. Use of prescription or non-prescription drugs, including herbal and dietary supplements within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication 16. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that contraindicates their participation. 17. Where participation in the study would result in don
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the efficacy of GSK239512 on cognitive function in subjects with mild to moderate Alzheimer’s disease after 16 weeks of treatment; Primary end point(s): - Change from baseline in the executive function/working memory composite score in the CogState battery at week 16. -Change in baseline in the episodic memory composite score in the CogState battery at week 16 ; Secondary Objective: • To assess the efficacy of GSK239512 on global clinical status after 16 weeks of treatment. • To assess the effects of GSK239512 on patients’ and carers’ perception of clinical status after 16 weeks of treatment. • To assess the effects of GSK239512 on neuropsychiatric or behavioural symptoms after 16 weeks of treatment. • To assess the effects of GSK239512 on activities of daily living after 16 weeks of treatment. • To assess the safety and tolerability of GSK239512 after 16 weeks of treatment. • To estimate the systemic exposure to GSK239512 during the 16 weeks of treatment. • To investigate any relationship between systemic exposure of GSK239512 with changes in cognitive function or other efficacy outcome measures. | — |
Countries
Bulgaria, Czech Republic, Germany, Slovakia, United Kingdom
Outcome results
None listed