Trial · NCT07105709
Open-label Extension Study in Participants With Early Alzheimer's Disease
NCT07105709, Phase 2, Recruiting, GlaxoSmithKline
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-label Extension Study in Participants With Early Alzheimer's Disease. Trials, record NCT07105709. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07105709
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-label Extension Study in Participants With Early Alzheimer's Disease
- NCT number
- NCT07105709
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 220 participants, estimated
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Alzheimer's Disease
- Interventions
- GSK4527226
- First posted
- 2025-08-06
- Last updated
- 2026-02-02
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants with Treatment Emergent Adverse Events (AEs) during the OLE | Up to 112 Weeks | 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. |
| Primary | Number of Participants with Adverse Event of Special Interest (AESIs) during the OLE | Up to 112 Weeks | AESIs includes Infusion-related reactions, Amyloid related imaging abnormalities (ARIA) and cerebral macrohemorrhage. |
| Primary | Number of Participants with Serious Adverse Events (SAEs) during the OLE | Up to 112 Weeks | 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. |
| Primary | Number of Participants with Amyloid related imaging abnormalities (ARIAs) Including Severity during the OLE | Up to 112 Weeks | 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. |
| Secondary | Change from OLE Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score Across Weeks 24, 52, 76, and 104 | Baseline, Week 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. |
| Secondary | Change from OLE Baseline in AD Assessment Scale-Cognitive subscale (ADAS-Cog14) Score Across Weeks 24, 52, 76, and 104 | Baseline, Week 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. |
| Secondary | Change from OLE Baseline in Mini - Mental State Exam (MMSE) Across Weeks 24, 52, 76, and 104 | Baseline, Week 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. |
| Secondary | Change from OLE Baseline in ADCS-ADL-MCI Score Across Weeks 24, 52, 76, and 104 | Baseline, Week 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. |
| Secondary | Change from OLE Baseline in Integrated Alzheimers Disease Rating Scale (iADRS) Score Across Weeks 24, 52, 76, and 104 | Baseline, Week 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. |
| Secondary | Change from OLE Baseline in Alzheimers Disease Composite Score (ADCOMS) Across Weeks 24, 52, 76 and 104 | Baseline, Week 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07105709
GET https://conductscience.org/api/trials/v1/NCT07105709/registered