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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521107-42 | Registry Identifier | EU CTIS |
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| Name | Class |
|---|---|
| Alector Inc. | INDUSTRY |
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The study medicine GSK4527226 is being studied in participants with Alzheimer's Disease (AD) in study 219867 (the parent study, NCT06079190). This new study is an extension of that parent study called an open-label extension (OLE). An OLE is a clinical trial where all participants receive the same study medicine. Participants must already be in study 219867 to be able to take part in this study. This study will assess the long-term safety and efficacy of GSK4527226 in participants with early AD (including mild cognitive impairment [MCI] and mild dementia due to AD) who have completed the parent study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK4527226 | Experimental | Participants will receive GSK4527226. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK4527226 | Drug | GSK4527226 will be administered. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment Emergent Adverse Events (AEs) during the OLE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. | Up to 112 Weeks |
| Number of Participants with Adverse Event of Special Interest (AESIs) during the OLE | AESIs includes Infusion-related reactions, Amyloid related imaging abnormalities (ARIA) and cerebral macrohemorrhage. | Up to 112 Weeks |
| Number of Participants with Serious Adverse Events (SAEs) during the OLE | A SAE is defined as any untoward medical occurrence that, at any dose, results in death and is life threatening requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a birth defect or congenital anomaly. | Up to 112 Weeks |
| Number of Participants with Amyloid related imaging abnormalities (ARIAs) Including Severity during the OLE | Magnetic resonance imaging (MRIs) will be used to monitor for abnormalities in the brain such as brain swelling and/or brain bleeding, which are termed as ARIAs. | Up to 112 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from OLE Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score Across Weeks 24, 52, 76, and 104 | The CDR-SB score is a quantitative general index that provides more precision in participants with mild dementia. The CDR scale is a clinician-rated dementia staging system tracks the progression of cognitive impairment in 6 categories (memory, orientation, judgment, and problem solving, community affairs, home and hobbies, and personal care). Each category is scored on a 5- point scale in which 0=None, 0.5=Questionable, 1= Mild, 2=Moderate, and 3=Severe. The CDR-SB score is obtained by adding the ratings in each of the 6 categories and total score ranges from 0 to 18 with higher scores indicative of greater impairment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US GSK Clinical Trials Call Center | Contact | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
| EU GSK Clinical Trials Call Center | Contact | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Recruiting | Maitland | Florida | 32752 | United States |
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
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This is an open-label study.
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| Baseline, Week 24, 52, 76, and 104 |
| Change from OLE Baseline in AD Assessment Scale-Cognitive subscale (ADAS-Cog14) Score Across Weeks 24, 52, 76, and 104 | The AD Assessment Scale-Cognitive subscale (ADAS-Cog14) is a 14-item version of the test that assesses immediate and delayed memory, confrontational naming, ability to follow commands, ideational and constructional praxis, orientation, language, and attention. The ADAS Cog-14 score ranges from 0 to 90 and higher scores indicate greater impairment. | Baseline, Week 24, 52, 76, and 104 |
| Change from OLE Baseline in Mini - Mental State Exam (MMSE) Across Weeks 24, 52, 76, and 104 | The MMSE is a brief test used to screen for cognitive impairment. It is routinely used for estimating the severity of cognitive impairment and tracking cognitive changes in an individual over time. The MMSE assesses orientation (time and place), registration, attention and calculation, recent memory, language (naming, comprehension, and repetition), and constructional praxis (copying a figure). The MMSE score ranges from 0 to 30, with higher scores indicating better cognitive performance. | Baseline, Week 24, 52, 76, and 104 |
| Change from OLE Baseline in ADCS-ADL-MCI Score Across Weeks 24, 52, 76, and 104 | The AD Cooperative Study - Activities of Daily Living Scale for use in Mild Cognitive Impairment (ADCS-ADL-MCI). The ADCS-ADL for MCI is a 23-item scale that measures the competence of participants in basic and instrumental activities of daily living. Total scores on the ADCS-ADL-MCI range from 0 to 53 where lower scores indicates greater functional impairment. | Baseline, Week 24, 52, 76, and 104 |
| Change from OLE Baseline in Integrated Alzheimers Disease Rating Scale (iADRS) Score Across Weeks 24, 52, 76, and 104 | The iADRS is a composite tool that measures both cognition and function. The iADRS combines scores from the ADAS-Cog-14 and the Alzheimer's Disease Cooperative Study-instrumental Activities of Daily Living (ADCS-iADL). The ADAS-Cog-14 is a 14-item version of the test that assesses immediate and delayed memory, confrontational naming, ability to follow commands, ideational and constructional praxis, orientation, language, and attention. The ADCS-iADL is a 23-item scale measuring basic and instrumental abilities in participants with mild to moderate AD. The iADRS score is then computed as the sum of the transformed ADAS-Cog14 and the ADCS-iADL with scores ranging from 0 to 144 and lower scores indicating worse performance. | Baseline, Week 24, 52, 76, and 104 |
| Change from OLE Baseline in Alzheimers Disease Composite Score (ADCOMS) Across Weeks 24, 52, 76 and 104 | The ADCOMS is a composite score comprising scores from the MMSE, ADAS-Cog14, and CDR-SB. It contains a total of 12 cognitive and functional items, including 4 items from the ADAS-Cog14, 2 items from the MMSE, and 6 items from the CDR-SB. The ADCOMS scores range from 0 to 1.97, with a higher score indicative of greater impairment. | Baseline, Week 24, 52, 76 and 104 |
| GSK Investigational Site | Recruiting | Miami | Florida | 33176 | United States |
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| GSK Investigational Site | Recruiting | Stuart | Florida | 34997 | United States |
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| GSK Investigational Site | Recruiting | Toms River | New Jersey | 08755 | United States |
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| GSK Investigational Site | Recruiting | Staten Island | New York | 10314 | United States |
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| GSK Investigational Site | Recruiting | Matthews | North Carolina | 28105 | United States |
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| GSK Investigational Site | Recruiting | Oklahoma City | Oklahoma | 73112 | United States |
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| GSK Investigational Site | Recruiting | Houston | Texas | 77030 | United States |
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| GSK Investigational Site | Recruiting | Fairfax | Virginia | 22031 | United States |
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| GSK Investigational Site | Recruiting | Buenos Aires | 1897 | Argentina |
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| GSK Investigational Site | Recruiting | Buenos Aires | C1425AGC | Argentina |
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| GSK Investigational Site | Recruiting | Ciudad Autonoma de Buenos Aire | C1431FWO | Argentina |
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| GSK Investigational Site | Recruiting | Ciudad Autonoma de Bueno | C1056ABJ | Argentina |
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| GSK Investigational Site | Recruiting | Macquarie Park | New South Wales | 2113 | Australia |
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| GSK Investigational Site | Recruiting | Nedlands | Western Australia | 6009 | Australia |
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| GSK Investigational Site | Recruiting | Ottawa | Ontario | K1Z 1G3 | Canada |
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| GSK Investigational Site | Recruiting | Peterborough | Ontario | K9H 2P4 | Canada |
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| GSK Investigational Site | Recruiting | Toronto | Ontario | M3B 2S7 | Canada |
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| GSK Investigational Site | Recruiting | Greenfield Park | Quebec | J4V 2J2 | Canada |
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| GSK Investigational Site | Recruiting | Sherbrooke | Quebec | J1J 2G2 | Canada |
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| GSK Investigational Site | Recruiting | Oulu | 90100 | Finland |
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| GSK Investigational Site | Recruiting | Bergen | 5009 | Norway |
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| GSK Investigational Site | Recruiting | Oslo | 0450 | Norway |
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| GSK Investigational Site | Recruiting | Junggu | 400711 | South Korea |
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| GSK Investigational Site | Recruiting | Barcelona | 08028 | Spain |
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| GSK Investigational Site | Recruiting | Gothenburg | 431 41 | Sweden |
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| GSK Investigational Site | Recruiting | Malmö | 21146 | Sweden |
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| GSK Investigational Site | Recruiting | Stockholm | Sweden |
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| GSK Investigational Site | Recruiting | Tainan | 704 | Taiwan |
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| GSK Investigational Site | Recruiting | Taoyuan | 333 | Taiwan |
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| GSK Investigational Site | Recruiting | Birmingham | B16 8LT | United Kingdom |
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| GSK Investigational Site | Recruiting | Bristol | BS32 4SY | United Kingdom |
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| GSK Investigational Site | Recruiting | London | W1G 8TA | United Kingdom |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
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