A Study of SB-742457, Added to Donepezil for the Treatment of Mild-to-moderate Alzheimer's Disease

Study AZ3110866, a Fixed Dose Study of SB-742457 Versus Placebo When Added to Existing Donepezil Treatment in Subjects With Mild-to-moderate Alzheimer's Disease

The study is designed to investigate the safety and efficacy of SB-742457 when added to stable donepezil treatment in subjects with mild-to-moderate Alzheimer's disease.

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: SB-742457 15mg; Drug: donepezil 5-10mg; Drug: Placebo; Drug: SB-742457 35mg

• Study Type: Interventional
• Enrollment (Actual): 682
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1425
    • GSK Investigational Site
  • Santa Fe, Argentina, 3000
    • GSK Investigational Site
  • Buenos Aires
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1405BCH
      • GSK Investigational Site
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1022AAO
      • GSK Investigational Site
    • Ciudad de Buenos Aires, Buenos Aires, Argentina, C1431FWO
      • GSK Investigational Site
    • La Plata, Buenos Aires, Argentina, B1900AVG
      • GSK Investigational Site
  • Córdova
    • Cordoba, Córdova, Argentina, 5000
      • GSK Investigational Site
• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • GSK Investigational Site
  • Queensland
    • Herston, Queensland, Australia, 4029
      • GSK Investigational Site
  • South Australia
    • Woodville, South Australia, Australia, 5011
      • GSK Investigational Site
  • Victoria
    • Ballarat, Victoria, Australia, 3350
      • GSK Investigational Site
    • Heidelberg West, Victoria, Australia, 3084
      • GSK Investigational Site
    • Kew, Victoria, Australia, 3101
      • GSK Investigational Site
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • GSK Investigational Site
• Canada
  • Québec, Canada, G1R 3X5
    • GSK Investigational Site
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 3L6
      • GSK Investigational Site
  • Nova Scotia
    • Kentville, Nova Scotia, Canada, B4N 4K9
      • GSK Investigational Site
  • Ontario
    • Ottawa, Ontario, Canada, K1G 4G3
      • GSK Investigational Site
    • Peterborough, Ontario, Canada, K9H 2P4
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M6M 3Z5
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M3B 2S7
      • GSK Investigational Site
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2J2
      • GSK Investigational Site
    • Montreal, Quebec, Canada, H1T 2M4
      • GSK Investigational Site
    • Sherbrooke, Quebec, Canada, J1H 1Z1
      • GSK Investigational Site
    • Sherbrooke, Quebec, Canada, J1J 3H5
      • GSK Investigational Site
• Chile
  • Santiago, Chile
    • GSK Investigational Site
  • Región Metro De Santiago
    • Santiago, Región Metro De Santiago, Chile, 7560356
      • GSK Investigational Site
    • Santiago, Región Metro De Santiago, Chile, 7510186
      • GSK Investigational Site
  • Valparaíso
    • Viña del Mar, Valparaíso, Chile, 252-0997
      • GSK Investigational Site
• Czechia
  • Melnik, Czechia, 27601
    • GSK Investigational Site
  • Olomouc, Czechia, 775 20
    • GSK Investigational Site
  • Ostrava, Czechia, 702 00
    • GSK Investigational Site
  • Pardubice, Czechia, 53203
    • GSK Investigational Site
  • Plzen, Czechia, 301 00
    • GSK Investigational Site
  • Praha 1, Czechia, 110 00
    • GSK Investigational Site
  • Praha 10, Czechia, 10000
    • GSK Investigational Site
  • Praha 4, Czechia, 14059
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 10961
    • GSK Investigational Site
  • Berlin, Germany, 12163
    • GSK Investigational Site
  • Berlin, Germany, 13439
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • Ellwangen, Baden-Wuerttemberg, Germany, 73479
      • GSK Investigational Site
    • Stuttgart, Baden-Wuerttemberg, Germany, 70176
      • GSK Investigational Site
    • Tuebingen, Baden-Wuerttemberg, Germany, 72076
      • GSK Investigational Site
    • Ulm, Baden-Wuerttemberg, Germany, 89075
      • GSK Investigational Site
  • Bayern
    • Alzenau, Bayern, Germany, 63755
      • GSK Investigational Site
    • Guenzburg, Bayern, Germany, 89312
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 81675
      • GSK Investigational Site
    • Regensburg, Bayern, Germany, 93053
      • GSK Investigational Site
    • Unterhaching, Bayern, Germany, 82008
      • GSK Investigational Site
  • Hessen
    • Bad Homburg, Hessen, Germany, 61348
      • GSK Investigational Site
  • Mecklenburg-Vorpommern
    • Schwerin, Mecklenburg-Vorpommern, Germany, 19055
      • GSK Investigational Site
    • Schwerin, Mecklenburg-Vorpommern, Germany, 19053
      • GSK Investigational Site
  • Niedersachsen
    • Achim, Niedersachsen, Germany, 28832
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Aachen, Nordrhein-Westfalen, Germany, 52062
      • GSK Investigational Site
    • Bad Honnef, Nordrhein-Westfalen, Germany, 53604
      • GSK Investigational Site
    • Bochum, Nordrhein-Westfalen, Germany, 44869
      • GSK Investigational Site
  • Sachsen
    • Dresden, Sachsen, Germany, 01309
      • GSK Investigational Site
    • Dresden, Sachsen, Germany, 01097
      • GSK Investigational Site
  • Thueringen
    • Jena, Thueringen, Germany, 07743
      • GSK Investigational Site
• Italy
  • Abruzzo
    • Chieti Scalo, Abruzzo, Italy, 66013
      • GSK Investigational Site
  • Campania
    • Napoli, Campania, Italy, 80131
      • GSK Investigational Site
    • San Felice A Cancello - Caserta, Campania, Italy, 81027
      • GSK Investigational Site
  • Lazio
    • Cassino (FR), Lazio, Italy, 03043
      • GSK Investigational Site
    • Roma, Lazio, Italy, 00163
      • GSK Investigational Site
    • Roma, Lazio, Italy, 00148
      • GSK Investigational Site
  • Lombardia
    • Brescia, Lombardia, Italy, 25125
      • GSK Investigational Site
    • Castellanza (VA), Lombardia, Italy, 21053
      • GSK Investigational Site
    • Milano, Lombardia, Italy, 20132
      • GSK Investigational Site
    • Milano, Lombardia, Italy, 20122
      • GSK Investigational Site
    • Rho, Lombardia, Italy, 20017
      • GSK Investigational Site
  • Piemonte
    • Torino, Piemonte, Italy, 10126
      • GSK Investigational Site
  • Toscana
    • Lido Di Camaiore (LU), Toscana, Italy, 55043
      • GSK Investigational Site
    • Pisa, Toscana, Italy, 56126
      • GSK Investigational Site
  • Umbria
    • Perugia, Umbria, Italy, 06156
      • GSK Investigational Site
  • Veneto
    • Valdagno (VI), Veneto, Italy, 36078
      • GSK Investigational Site
    • Verona, Veneto, Italy, 37126
      • GSK Investigational Site
• Spain
  • Baracaldo/Vizcaya, Spain, 48903
    • GSK Investigational Site
  • Barcelona, Spain, 08003
    • GSK Investigational Site
  • Barcelona, Spain, 08907
    • GSK Investigational Site
  • Barcelona, Spain, 08014
    • GSK Investigational Site
  • Burgos, Spain, 09006
    • GSK Investigational Site
  • Castellón, Spain, 12004
    • GSK Investigational Site
  • Madrid, Spain, 28006
    • GSK Investigational Site
  • Murcia, Spain, 30120
    • GSK Investigational Site
  • Salamanca, Spain, 37007
    • GSK Investigational Site
  • San Sebastián, Spain, 20014
    • GSK Investigational Site
  • San Vicente Del Raspeig/Alicante, Spain, 03690
    • GSK Investigational Site
  • Valencia, Spain, 46010
    • GSK Investigational Site
• United States
  • Arizona
    • Litchfield Park, Arizona, United States, 85340
      • GSK Investigational Site
  • California
    • Fresno, California, United States, 93720
      • GSK Investigational Site
    • Rancho Mirage, California, United States, 92270
      • GSK Investigational Site
    • San Francisco, California, United States, 94109
      • GSK Investigational Site
  • Florida
    • Hallandale Beach, Florida, United States, 33009
      • GSK Investigational Site
    • Hialeah, Florida, United States, 33016
      • GSK Investigational Site
  • New Jersey
    • Manchester, New Jersey, United States, 08759
      • GSK Investigational Site
  • New York
    • Syracuse, New York, United States, 13210
      • GSK Investigational Site
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • GSK Investigational Site
  • Ohio
    • Columbus, Ohio, United States, 43210
      • GSK Investigational Site
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • GSK Investigational Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • GSK Investigational Site
  • Texas
    • Austin, Texas, United States, 78757
      • GSK Investigational Site
  • Vermont
    • Bennington, Vermont, United States, 05201
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects and their caregivers must provide informed consent prior to study entry.
• Subjects must have a clinical diagnosis of probable mild-to-moderate Alzheimer's disease with no evidence of disorders that are thought to be the cause of, or contributing to the severity of the subject's dementia and a documented history of at least 6 months of ongoing donepezil therapy with stable dosing for at least the last 2 months.
• Subjects must have a regular caregiver who is willing to attend visits, oversee the subject's compliance with the study and report on the subject's status.
• Female subjects of child-bearing potential must agree to abstinence or an approved form of birth control.
• Subjects must have adequate blood pressure and laboratory values.

Exclusion Criteria:

• Subjects with a diagnosis of possible, probable or definite vascular dementia may not participate.
• Subjects with known hypersensitivity to sunlight or a history of seizures, previous exposure to SB-742457, taking agents for which there is a theoretical risk of interaction with SB-742457, or taking medication for Alzheimer's disease or centrally acting agents which might impact study outcomes may not participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DONEPEZIL + SB-742457 15 MG; SB-742457 - 15mg added to existing donepezil treatment	Drug: SB-742457 15mg; SB-742457 - 15mg added to existing donepezil treatment; Drug: donepezil 5-10mg; existing donepezil treatment
Placebo Comparator: DONEPEZIL + PLACEBO; Placebo added to existing donepezil	Drug: donepezil 5-10mg; existing donepezil treatment; Drug: Placebo; Placebo added to existing donepezil
Experimental: DONEPEZIL + SB-742457 35 MG; SB-742457 - 35mg added to existing donepezil	Drug: donepezil 5-10mg; existing donepezil treatment; Drug: SB-742457 35mg; SB-742457 - 35mg added to existing donepezil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score at Week 24	ADAS-cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. There were in all 11 questions. Total scores were calculated as the sum of the individual components. Scores ranged from 0 to 70 with higher scores indicated greater dysfunction. The ADAS-Cog total score was the sum of the calculated scores for questions 1, 2, and 7, and the scores recorded on the case report form (CRF) for questions 3 to 6 and 8 to 11. When a score was missing for one of the questions, the total score was calculated as a weighted average of the scores provided for the remaining ten questions. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean is presented.	Baseline(Week 0) and Week 24
Change From Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score at Week 24	The CDR-SB is an interviewer administered scale and impairment is scored in each of categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2 and severe = 3. The 6 individual category ratings, or "box scores", were added together to give the CDR-Sum of Boxes which ranges from 0-18 (severe impairment). If there were any missing items then CDR-SB was set to missing and was not imputed. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented.	Baseline(Week 0) and Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score at Week 24	RBANS is an individually administered cognitive battery comprising 12 subtests across five domains (Attention, Language, Visuospatial/Constructional Abilities, and Immediate and Delayed memory). Total scores are calculated by adding up the scores for each of the 12 individual subtests and ranges between 0 and 311, where a low score indicates greater impairment. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented.	Baseline (Week 0) and Week 24
Change From Baseline in ADAS-Cog Total Score at Week 12, 36 and 48	ADAS-cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. There were in all 11 questions. Total scores were calculated as the sum of the individual components. Scores ranged from 0 to 70 with higher scores indicated greater dysfunction. The ADAS-Cog total score was the sum of the calculated scores for questions 1, 2, and 7, and the scores recorded on the CRF for questions 3 to 6 and 8 to 11. In cases where more than one question was missing, a total score was not be imputed. When a score was missing for one of the questions, the total score was calculated as a weighted average of the scores provided for the remaining ten questions. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been present	Baseline (Week 0) and Week 12, 36 and 48
Change From Baseline in CDR-SB Score at Week 12, 36 and 48	The CDR-SB is an interviewer administered scale and impairment is scored in each of categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2 and severe = 3. The 6 individual category ratings, or "box scores", were added together to give the CDR-Sum of Boxes which ranges from 0-18 (severe impairment). If there were any missing items then CDR-SB was set to missing and was not imputed. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented.	Baseline (Week 0) and Week 12, 36, 48
Change From Baseline in RBANS Score at Week 12, 36 and 48	RBANS is an individually administered cognitive battery comprising 12 subtests across five domains (Attention, Language, Visuospatial/Constructional Abilities, and Immediate and Delayed memory). Total scores are calculated by adding up the scores for each of the 12 individual subtests and ranges between 0 and 311, where a low score indicates greater impairment. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented.	Baseline (Week 0) and Week 12, 36 and 48
Change From Baseline in Alzheimer's Disease Co-operative Study Group - Activities of Daily Living Inventory (ADCS- ADL) Total Score at Weeks 12, 24, 36 and 48	The ADCS-ADL is an interviewer-administered informant-based scale where the informant (caregiver) responds to 23 activities of daily living questions about the participant. The questions ranged from basic to instrumental activities of daily living and take approximately 20 minutes to complete. The Total score ranges from 0-78 and a higher score signified greater functional ability. The questionnaire was split into two types of questions, an initial question relating to whether a participant had completed a particular activity and then a follow on question which scored how much assistance the participant had required if they had performed that particular activity. The total score was calculated by adding up the responses for each of the individual activities. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented.	Baseline (Week 0) and Week 12, 24, 36 and 48
Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Week 24 and 48	The MMSE consisted of 11 items covering orientation, memory (recent and immediate), concentration, language and praxis. Scores ranged from 0 to 30, with lower scores indicating greater cognitive impairment. Scores for each of the 11 individual tests were not recorded on the CRF, therefore if any item was missing then the total score was be set to missing. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented.	Baseline (Week 0) and Week 24 and 48
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During Treatment Phase	An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.	Up to follow-up i.e. 2 weeks post end of treatment (Week 24, Week 48 or Early Withdrawal)
Number of Participants With Parameters of Clinical Concern - Hematology	Only parameters with values have been presented. Data has been reported for number of participants with high and/ or low values for Eosinophils (high-2), Hematocrit (low- 0.8, high-1.2), Lymphocytes (low-0.75, high-1.5), Mean Corpuscle Hemoglobin (MCH) (low-0.8, high-1.2), Monocytes(low-0.75, high-2), Neutrophil bands (high-10), Platelet count (low-100, high-500), Segmented Neutrophils (low-0.75, high-1.3), Total Neutrophils (low-0.75, high-1.5), and white blood cells (WBC) (low-3, high-15).	Up to Week 48
Number of Participants With Parameters of Clinical Concern - Clinical Chemistry	Only parameters with values have been presented. Data has been reported for number of participants with high and/ or low values for Alanine Amino Transferase (ALT) (high-1.5), Alkaline Phosphatase (high-1.5), Aspartate Amino Transferase (ASAT) (high-1.5), BUN/Creatinine ratio (high-1.5), Calcium (low- 0.75, high-1.25), Carbon dioxide content/Bicarbonate (low-15, high- 40), Cholesterol (high-1.25), Creatine Kinase ((low- 0.5, high-1.25), Creatinine (low- 0.5, high-1.25), Direct Bilirubin (high-1.5), Gamma Glutamyl Transferase (GGT) (high-2), Glucose (low- 3.6, high-7.8), HDL Cholesterol (low-0.65), LDL Cholesterol (hig-1.25), Magnesium (low-0.5, high-2), Phosphorus inorganic (low- 0.5, high-1.5), Potassium (low- 3, high-5.5), Sodium (low- 130, high-150), Total Bilirubin (high-1.5), Triglycerides (high -4) and Urea/BUN (high-11).	Up to Week 48
Exposure Estimates for SB-742457 : Area Under the Concentration Time Curve Over the Dosing Interval at Steady State (AUCτss)	AUCτss of SB-742457 was estimated via nonlinear mixed effect analysis. This pharmacokinetic(PK) model was a steady state one compartment model with first-order absorption, with between participant variability on clearance and volume of distribution.	Post-dose at 3, 8 and 24 hours on Week 0, 1, 3, 6, 12, 18, 24, 30, 36, 42 and 48
Exposure Estimates for SB-742457 : Minimum Concentrations at Steady State (Cmin-ss)	Cmin-ss was estimated via nonlinear mixed effect analysis. This PK model was a steady state one compartment model with first-order absorption, with between participant variability on clearance and volume of distribution.	Post-dose at 3, 8 and 24 hours on Week 0, 1, 3, 6, 12, 18, 24, 30, 36, 42 and 48
Exposure Estimates for Donepezil (Cavgss)	Participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) were allowed to participate in this study. Cavgss for donepezil approximately 12 to 20 hours after dosing were summarized by donepezil dose level 5 mg/7.5 mg/10 mg/15 mg.	Post-dose at 12 to 20 hours on Week 0, 1, 3, 6, 12, 18, 24, 30, 36, 42 and 48
Change From Baseline in ADAS-Cog Scale in Participants With APOE4 Gene	Genetic analyses was conducted to assess the effect of APOE4 carriage. ADAS-cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five-point scale. There were in all 11 questions. Total scores were calculated as the sum of the individual components. Scores ranged from 0 to 70 with higher scores indicating greater dysfunction. The ADAS-Cog total score was the sum of the calculated scores for questions 1, 2, and 7, and the scores were recorded on the CRF for questions 3 to 6 and 8 to 11. When a score was missing for one of the questions, the total score was calculated as a weighted average of the scores provided for the remaining ten questions. Baseline was Week 0 value. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value.	Baseline (Week 0) to Week 24 and Week 48
Change From Baseline in CDR-SB Scale in Participants With APOE4 Gene	Genetic analyses was conducted to assess the effect of APOE4 carriage. The CDR-SB is an interviewer administered scale and impairment is scored in following categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment was scored on a scale in which none =0, questionable =0.5, mild =1, moderate =2 and severe =3. The 6 individual category ratings, or "box scores", were added together to give the CDR-Sum of Boxes which ranges from 0-18, with higher score indicating severe impairment. If there were any missing items then CDR-SB was set to missing and was not imputed. Baseline was Week 0 value. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value.	Baseline (Week 0) to Week 24 and Week 48
Change From Baseline in RBANS Scale in Participants With APOE4 Gene	Genetic analyses was conducted to assess the effect of APOE4 carriage. RBANS is an individually administered cognitive battery comprising 12 subtests across five domains (Attention, Language, Visuospatial/Constructional Abilities, and Immediate and Delayed memory). Total scores are calculated by adding up the scores for each of the 12 individual subtests and ranges between 0 and 311, where a low score indicates greater impairment. Baseline was Week 0 value. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value.	Baseline (Week 0) to Week 24 and Week 48

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Maher-Edwards G, Watson C, Ascher J, Barnett C, Boswell D, Davies J, Fernandez M, Kurz A, Zanetti O, Safirstein B, Schronen JP, Zvartau-Hind M, Gold M. Two randomized controlled trials of SB742457 in mild-to-moderate Alzheimer's disease. Alzheimers Dement (N Y). 2015 May 7;1(1):23-36. doi: 10.1016/j.trci.2015.04.001. eCollection 2015 Jun.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2008
• Primary Completion (Actual): May 21, 2010
• Study Completion (Actual): November 16, 2010

Study Registration Dates

• First Submitted: June 30, 2008
• First Submitted That Met QC Criteria: July 3, 2008
• First Posted (Estimate): July 4, 2008

Study Record Updates

• Last Update Posted (Actual): December 7, 2017
• Last Update Submitted That Met QC Criteria: November 3, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Alzheimer's disease cognition SB-742457
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Donepezil
• Other Study ID Numbers: AZ3110866