Actively Recruiting

Phase 2
Age: 50Years - 85Years
All Genders
NCT07105709

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

Age: 50Years - 85Years
All Genders

Eligibility Criteria

Eligible

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or temporarily suspended dosing during the Treatment Period but must not have permanently stopped study medication or withdrawn from the parent study.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.
Not Eligible

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

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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

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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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