Actively Recruiting
Open-label Extension Study in Participants With Early Alzheimer's Disease
Led by GlaxoSmithKline · Updated on 2026-02-02
220
Participants Needed
33
Research Sites
173 weeks
Total Duration
On this page
Sponsors
G
GlaxoSmithKline
Lead Sponsor
A
Alector Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Open-label Extension Study in Participants With Early Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Completion of the Treatment Period in the parent study (NCT06079190).
- Participants may have missed doses or temporarily suspended dosing during the Treatment Period but must not have permanently stopped study medication or withdrawn from the parent study.
- Willing and able to give informed consent and comply with study requirements.
- Availability of an adult who has frequent and sufficient contact with the participant to provide accurate information and who agrees to sign the study partner consent form.
- Female participants must not be pregnant or breastfeeding and must follow contraception requirements if of childbearing potential.
- Male participants must follow contraception requirements as outlined in the protocol.
You will not qualify if you...
- QT interval corrected (QTc) test at Day 1 meets stopping criteria in the protocol.
- Taking or planning to start prohibited medications listed in the protocol.
- Evidence of amyloid related imaging abnormalities (ARIA) or cerebral macrohemorrhage requiring permanent discontinuation.
- Newly identified brain conditions such as intracranial hemorrhage, aneurysm, vascular malformation, infection, tumor, or MRI findings that contraindicate study participation.
- New infections affecting the central nervous system.
- New diagnosis of moderate to severe alcohol or substance use disorder.
- Inability to tolerate MRI procedures or contraindications to MRI.
- Newly diagnosed cancer.
- Severe allergic or hypersensitivity reactions to antibodies or fusion proteins.
- Newly identified genetic clotting or bleeding disorders.
- Any other significant health changes making participation unsuitable as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 33 locations
1
GSK Investigational Site
Maitland, Florida, United States, 32752
Actively Recruiting
2
GSK Investigational Site
Miami, Florida, United States, 33176
Actively Recruiting
3
GSK Investigational Site
Stuart, Florida, United States, 34997
Actively Recruiting
4
GSK Investigational Site
Toms River, New Jersey, United States, 08755
Actively Recruiting
5
GSK Investigational Site
Staten Island, New York, United States, 10314
Actively Recruiting
6
GSK Investigational Site
Matthews, North Carolina, United States, 28105
Actively Recruiting
7
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Actively Recruiting
8
GSK Investigational Site
Houston, Texas, United States, 77030
Actively Recruiting
9
GSK Investigational Site
Fairfax, Virginia, United States, 22031
Actively Recruiting
10
GSK Investigational Site
Buenos Aires, Argentina, 1897
Actively Recruiting
11
GSK Investigational Site
Buenos Aires, Argentina, C1425AGC
Actively Recruiting
12
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, Argentina, C1431FWO
Actively Recruiting
13
GSK Investigational Site
Ciudad Autonoma de Bueno, Argentina, C1056ABJ
Actively Recruiting
14
GSK Investigational Site
Macquarie Park, New South Wales, Australia, 2113
Actively Recruiting
15
GSK Investigational Site
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
16
GSK Investigational Site
Ottawa, Ontario, Canada, K1Z 1G3
Actively Recruiting
17
GSK Investigational Site
Peterborough, Ontario, Canada, K9H 2P4
Actively Recruiting
18
GSK Investigational Site
Toronto, Ontario, Canada, M3B 2S7
Actively Recruiting
19
GSK Investigational Site
Greenfield Park, Quebec, Canada, J4V 2J2
Actively Recruiting
20
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1J 2G2
Actively Recruiting
21
GSK Investigational Site
Oulu, Finland, 90100
Actively Recruiting
22
GSK Investigational Site
Bergen, Norway, 5009
Actively Recruiting
23
GSK Investigational Site
Oslo, Norway, 0450
Actively Recruiting
24
GSK Investigational Site
Junggu, South Korea, 400711
Actively Recruiting
25
GSK Investigational Site
Barcelona, Spain, 08028
Actively Recruiting
26
GSK Investigational Site
Gothenburg, Sweden, 431 41
Actively Recruiting
27
GSK Investigational Site
Malmö, Sweden, 21146
Actively Recruiting
28
GSK Investigational Site
Stockholm, Sweden
Actively Recruiting
29
GSK Investigational Site
Tainan, Taiwan, 704
Actively Recruiting
30
GSK Investigational Site
Taoyuan, Taiwan, 333
Actively Recruiting
31
GSK Investigational Site
Birmingham, United Kingdom, B16 8LT
Actively Recruiting
32
GSK Investigational Site
Bristol, United Kingdom, BS32 4SY
Actively Recruiting
33
GSK Investigational Site
London, United Kingdom, W1G 8TA
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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