Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as donepezil
SB-742457 · 5 trials · 1 indication
ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items are evaluated by tests, but some are dependent on clinician ratings on a five point scale. The ADAS-Cog total score is the sum of the calculated scores for Questions 1 (Word recall task), 2 (Naming objects and fingers), and 7 (Word recognition task) and the scores recorded on the CRF for Questions 3 to 6 (Commands, Constructional praxis, Ideational praxis, Orientation) and 8 to 11 (Remembering test instructions, Spoken language ability, Word finding difficulty in spontaneous speech, Comprehension). The total score ranges from 0-70 with higher scores indicating greater dysfunction while lower indicates better cognitive function. Baseline was defined as the value at Week 0. Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.
The CIBIC+ is a rating scale derived from an interview with the participant and caregiver with an independent rater designed to measure several domains of participant function, such as mental/cognitive state, behavior, and functioning. The scores are rated on a scale of 1 to 7 as follows: 1 (marked improvement), 2 (moderately improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (moderately worse) and 7 (markedly worse).
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.
| Arm | Type | Description |
|---|---|---|
| SB-742457 - 15mg | EXPERIMENTAL | SB-742457 - 15mg |
| Placebo | PLACEBO_COMPARATOR | - |
| SB-742457 - 35mg | EXPERIMENTAL | SB-742457 - 35mg |
| Donepezil | ACTIVE_COMPARATOR | - |
| DONEPEZIL + SB-742457 15 MG | EXPERIMENTAL | SB-742457 - 15mg added to existing donepezil treatment |
| DONEPEZIL + PLACEBO | PLACEBO_COMPARATOR | Placebo added to existing donepezil |
| DONEPEZIL + SB-742457 35 MG | EXPERIMENTAL | SB-742457 - 35mg added to existing donepezil |
| Name | Type | Description |
|---|---|---|
| SB-742457 | DRUG | investigational drug |
| Donepezil | DRUG | comparator |
| Placebo | DRUG | comparator |
| SB-742457 15mg | DRUG | SB-742457 - 15mg added to existing donepezil treatment |
| SB-742457 35mg | DRUG | SB-742457 - 35mg added to existing donepezil |
| donepezil 5-10mg | DRUG | existing donepezil treatment |
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 a documented 6-month history of AD symptoms * Subjects must have a regular caregiver who is willing...
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SB-742457 is an investigational small molecule developed for the treatment of Alzheimer's disease. It has been studied in patients with mild-to-moderate Alzheimer's disease, both as add-on therapy to donepezil and as monotherapy compared with donepezil and placebo. It is not approved for any indication.
SB-742457 is being developed by GSK plc, which trades on the New York Stock Exchange under the ticker GSK. GSK sponsored the clinical trial program for the compound in Alzheimer's disease.
SB-742457 is in Phase 2 clinical development. Five trials have been completed, including Phase 2 studies in mild-to-moderate Alzheimer's disease and a Phase 1 pharmacokinetic study in healthy elderly volunteers. No trials are currently active. The drug is investigational and has not been approved.
SB-742457 has been evaluated in completed trials including NCT00710684, which added SB-742457 to donepezil in 682 patients with mild-to-moderate Alzheimer's disease; NCT00708552, comparing SB-742457 or donepezil with placebo in 576 patients; NCT00348192, a 200-patient Phase 2 study; and NCT00551772, a Phase 1 pharmacokinetic study in 12 healthy elderly volunteers.