Efficacy and Safety of GSK4527226 [AL101] in Participants With Early Alzheimer's Disease (PROGRESS-AD)

February 12, 2024 updated by: GlaxoSmithKline

A Phase 2, Parallel Group, Randomized, Double- Blind, Placebo-Controlled, 3-Arm, Multicenter Treatment Study to Evaluate the Efficacy and Safety of GSK4527226 [AL101] Intravenous Infusion Compared With Placebo in Patients With Early Alzheimer's Disease

The aim of this study is to assess the efficacy and safety of GSK4527226 in participants with early Alzheimer's Disease (AD) (including mild cognitive impairment [MCI] and mild dementia due to AD) of 2 dose levels of GSK4527226 compared to placebo.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

282

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1056ABJ
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Griselda Russo
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, C1428AQK
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ricardo Allegri
        • Contact:
        • Contact:
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1431FWO
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Diego Castro
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rebekah Ahmed
      • Darlinghurst, New South Wales, Australia, 2010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bruce Brew
      • Kogarah, New South Wales, Australia, 2217
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Raymond Schwartz
      • Macquarie Park, New South Wales, Australia, 2113
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rosalyn Lai
    • Queensland
      • Southport, Queensland, Australia, 4222
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Philip Morris
    • Victoria
      • Ivanhoe, Victoria, Australia, 3079
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Woodward
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Darby
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Roger Clarnette
        • Contact:
        • Contact:
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Z 1G3
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Richard Bergeron
        • Contact:
        • Contact:
      • Peterborough, Ontario, Canada, K9H 2P4
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sarah Brisbin
        • Contact:
        • Contact:
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Carmela Tartaglia
      • Toronto, Ontario, Canada, M3B 2S7
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sharon Cohen
        • Contact:
        • Contact:
    • Quebec
      • Greenfield-Park, Quebec, Canada, J4V 2J2
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ziad Nasreddine
        • Contact:
        • Contact:
      • Sherbrooke, Quebec, Canada, J1J 2G2
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paule Royer
      • Verdun, Quebec, Canada, H4H 1R3
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Simon Ducharme
        • Contact:
        • Contact:
  • Finland
      • Helsinki, Finland, 00180
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zsofia Lovro
      • Kuopio, Finland, 70210
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sudhir Kurl
      • Oulu, Finland, 90100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hanna Ansakorpi
      • Turku, Finland, 20520
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juha Rinne
  • France
      • Bron, France, 69500
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hélène Mollion
      • Lille Cedex, France, 59037
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marie-Anne Mackowiak
      • Nice, France, 06100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guillaume SACCO
      • Paris, France, 75010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Claire Paquet
      • Paris, France, 75013
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Stéphanie Bombois
        • Contact:
        • Contact:
      • Saint-Herblain, France, 44093
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Claire Boutoleau-Bretonniere
      • Strasbourg, France, 67200
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Frederic Blanc
      • Toulouse, France, 31300
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pierre-Jean Ousset
      • Villeurbanne, France, 69100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jing Xie
  • Germany
    • Bayern
      • Muenchen, Bayern, Germany, 80336
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Robert Perneczky
    • Hessen
      • Erbach, Hessen, Germany, 64711
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gerd Reifschneider
    • Nordrhein-Westfalen
      • Koeln, Nordrhein-Westfalen, Germany, 50935
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gereon Nelles
      • Muenster, Nordrhein-Westfalen, Germany, 48149
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Matthias Pawlowski
  • Italy
      • Brescia, Italy, 25123
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Alessandro Padovani
        • Contact:
        • Contact:
      • Milano, Italy, 20132
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Massimo Filippi
        • Contact:
        • Contact:
      • Milano, Italy, 20133
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Paola Caroppo
        • Contact:
        • Contact:
      • Monza, Italy, 20900
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carlo Ferrarese
      • Palermo, Italy, 90127
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Salvatore Cottone
      • Perugia, Italy, 06129
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lucilla Parnetti
    • Lazio
      • Roma, Lazio, Italy, 00179
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francesco Di Lorenzo
    • Liguria
      • Genova, Liguria, Italy, 16132
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Matteo Pardini
    • Modena
      • Baggiovara, Modena, Italy, 41126
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Giovanna Zamboni
    • Palermo
      • Cefalù, Palermo, Italy, 90015
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Luigi Grimaldi
    • Pavia
      • Mondino, Pavia, Italy, 27100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alfredo Arturo Costa
  • Korea, Republic of
      • Jung Gu, Korea, Republic of, 400711
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Seong Hye Choi
      • Seoul, Korea, Republic of, 138-736
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jae-Hong Lee
      • Seoul, Korea, Republic of, 04763
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hee Jin Kim
  • Netherlands
      • 's-Hertogenbosch, Netherlands, 5223 LA
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paul L.J. Dautzenberg
      • Amsterdam, Netherlands, 1081 GN
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jort Vijverberg
        • Contact:
        • Contact:
      • Zwolle, Netherlands, 8025 AZ
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paul L.J. Dautzenberg
  • Norway
      • Bergen, Norway, 5009
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ragnhild Eide Skogseth
      • Drammen, Norway, N-3004
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sylvia Leiro Baastad
      • Oslo, Norway, 0450
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anne-Brita Knapskog
      • Stavanger, Norway
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Audun Osland Vik-Mo
  • Spain
      • Barcelona, Spain, 08028
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Merce Boada Rovira
      • Getxo, Spain, 48993
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Manuel Fernandez Martinez
      • Madrid, Spain, 28046
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ana Frank García
      • Madrid, Spain, 28034
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guillermo García Ribas
      • Madrid, Spain, 28041
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alberto Villarejo Galende
      • Pamplona, Spain, 31008
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Javier Sánchez Ruiz de Gordoa
      • Salamanca, Spain, 37007
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Angel Luis Montejo González
        • Contact:
        • Contact:
      • Terrassa (Barcelona), Spain, 08221
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jerzy Krupinski Bielecki
      • Valencia, Spain, 46026
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Miguel Baquero Toledo
    • Madrid
      • Pozuelo De Alarcón, Madrid, Spain, 28223
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rafael Arroyo Gonzalez
    • País Vasco
      • San Sebastian, País Vasco, Spain, 20009
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pablo Martínez-Lage
  • Sweden
      • Jönköping, Sweden, SE-551 85
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joel Holmqvist
      • Malmö, Sweden, 21146
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Henrik Östlund
      • Mölndal, Sweden, 431 41
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Jonsson
      • Stockholm, Sweden
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pia Andersen
  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chiung-Chih Chang
      • Tainan, Taiwan, 704
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ming-Chyi Pai
      • Taoyuan, Taiwan, 333
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chin-Chang Huang
  • Turkey
      • Ankara, Turkey, 06230
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gul Yalcin Cakmakli
      • Capa/Istanbul, Turkey, 34093
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Basar Bilgic
  • United Kingdom
      • Bristol, United Kingdom, BS32 4SY
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniel Lashley
      • London, United Kingdom, EC2Y 8EA
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stuart Ratcliffe
      • London, United Kingdom, W1G 9JF
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emer MacSweeney
      • London, United Kingdom, WC1N 3BG
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Catherine Mummery
        • Contact:
        • Contact:
      • Motherwell, United Kingdom, ML1 4UF
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jennifer Lynch
        • Contact:
        • Contact:
    • England
      • Birmingham, England, United Kingdom, B16 8LT
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Conor Clerkin-Oliver
        • Contact:
        • Contact:
  • United States
    • California
      • San Diego, California, United States, 92103
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Eric Michael Chavez
        • Contact:
        • Contact:
    • Florida
      • DeLand, Florida, United States, 32720
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bruce Glenn Rankin
      • Maitland, Florida, United States, 32752
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sheila Baez-Torres
      • Miami, Florida, United States, 33176
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ramon Leon
        • Contact:
        • Contact:
      • Orlando, Florida, United States, 32804
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Valeria Baldivieso
      • Stuart, Florida, United States, 34957
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paayal Patel
      • The Villages, Florida, United States, 32159
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Craig Curtis
        • Contact:
        • Contact:
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marshall L Nash
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Concetta Forchetti
        • Contact:
        • Contact:
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas Klein
    • Missouri
      • Chesterfield, Missouri, United States, 63005
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Siddharth Kaul
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sanjiv Sharma
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Martin J. Sadowski
      • New York, New York, United States, 10032
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lawrence S. Honig
      • Staten Island, New York, United States, 10314
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mark DiBuono
    • North Carolina
      • Matthews, North Carolina, United States, 28105
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mohammed Bolouri
    • Ohio
      • North Canton, Ohio, United States, 44720
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shishuka Malhotra
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carl P Griffin
    • Oregon
      • Portland, Oregon, United States, 07210
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Scott N. Losk
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jacobo Mintzer
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jontel Dansby Pierce
    • Virginia
      • Fairfax, Virginia, United States, 22030
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Raymond Turner

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Participant must be in the Alzheimer's continuum as defined by the 2018 National Institute on Aging and Alzheimer's Association (NIAAA) Research Framework corresponding to the clinical categories of MCI due to AD and mild AD dementia.

Participant must have evidence of amyloid positivity either by positive positron emission tomography (PET) result (Amyloid PET scans must be read by a central imaging lab) or cerebrospinal fluid (CSF) amyloid beta (Aβ) test result indicative of amyloid positivity

  • Participants must also meet the following criteria for clinical severity:

    1. MMSE score of between 21 and 29 points
    2. CDR-global score (GS) of 0.5 to 1.0.
    3. CDR Memory Box score greater than or equal to (≥) 0.5.
    4. Participants with objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler Memory Scale-IV Logical Memory II (WMS-IV LMII)
  • If the participant is receiving symptomatic AD medications such as an Acetylcholinesterase inhibitor (AChEI) or memantine, the dosing regimen must have been stable for at least 12 weeks prior to screening and is not expected to change during study participation.
  • If the participant is receiving other medications for AD related symptoms or associated conditions, the dosing regimen must have been stable for at least 4 weeks prior to screening and not expected to change during study participation. Symptoms must be considered adequately and stably controlled by the investigator, without marked changes in medication anticipated for the duration of the study.
  • Body weight ≥ 45 kilogram (kg) to less than or equal to (≤)120 kg with body mass index (BMI) between 17 and 34.9 kilogram per meter square (kg/m^2), inclusive.
  • A female participant is eligible to participate if she is not pregnant or breastfeeding, and if of child-bearing potential follows contraception requirements outlined in the protocol
  • A male participant is eligible to participate if he follows contraception requirements outlined in the protocol
  • Willing and able to give informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
  • Availability of an adult person who has frequent and sufficient contact with the participant is able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to provide information at clinic visits, and signs the ICF of the study partner.

Exclusion Criteria:

Participant has evidence of any neurological condition other than AD that may contribute to cognitive impairment.

  • History or presence of vascular disease that has the potential to affect cognitive function.
  • History or presence of stroke within the past 1 year or recent transient ischemic attack within 180 days before screening.
  • History of severe, clinically significant central nervous system (CNS) trauma.
  • History or presence of intracranial tumor.
  • Presence of ongoing infection(s) that may affect brain function, or history of infections that resulted in neurologic sequelae.
  • History of primary psychiatric diagnosis that the investigator considers may interfere with study assessments.

Columbia Suicide Severity Rating Scale (C-SSRS) suicidal ideation Type 4 or 5, suicidal behaviour or has been assessed to be at risk of suicide, in the opinion of the investigator within 6 months before screening, at screening, or at the Baseline visit, or has been hospitalized or treated for suicidal behaviour in the past 2 years.

  • Participant has history of alcohol and/or moderate to severe substance use disorder within the past 2 years

  • Magnetic resonance imaging (MRI) evidence based on central read of:

    1. >3 lacunar infarcts.
    2. Stroke involving a major vascular territory, severe small vessel, or white matter disease.
    3. Any territorial infarct >1 cubic centimetre (cm^3).
    4. White matter hyperintense lesions on the FLAIR sequence that correspond to an overall Fazekas score of 3
    5. >4 microhaemorrhages.
    6. Any areas of superficial (leptomeningeal) hemosiderosis.
    7. A single macro-hemorrhage greater than 10 millimetres (mm) at greatest diameter.
    8. Vasogenic edema.
    9. Cerebral contusion, encephalomalacia, aneurysms, vascular malformations, or infective lesions.
    10. Space occupying lesions or brain tumors.
    11. Significant cerebral vascular pathology
  • History suggestive of exposure to, or past tuberculosis (TB) infection should undergo screening for TB disease.
  • Chronic active immune disorder requiring systemic immunosuppressive therapy within 6 months prior to Screening.
  • Screening serum vitamin B12 concentration < Lower limit of normal (LLN) or in the low normal range
  • Folate <LLN or Thyroid-stimulating hormone (TSH) > Upper limit of normal (ULN)
  • Hemoglobin A1c >8 percentage (%) or poorly controlled diabetes during the last 12 weeks
  • History of cancer
  • Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins
  • Planned surgery during the study which requires general, spinal, or epidural anesthesia that would take place during the study.

  • Key exclusionary medications include:

    • Antipsychotics, opiates/opioids, cannabinoids, hypnotics, antidepressants, mood stabilizers, or stimulants that are used on a chronic basis, are exclusionary if not consistent with the following rule: treatment has to have been at a stable dose for at least 4 weeks before screening and should remain stable during the study
    • Any biologic drugs with systemic exposure, whether investigational or approved, used within 6 months before screening Any disease modification drug for AD, such as aducanumab and lecanemab, whether investigational or approved, used within 6 months before screening.
    • Anticoagulation medications within 90 days of screening and during the study
    • Systemic immunosuppressive therapy within 90 days before screening and during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo.
Other: Placebo
Placebo will be administered.
Experimental: GSK4527226 Dose 1
Participants will receive GSK4527226 Dose 1
Drug: GSK4527226
GSK4527226 will be administered.
Experimental: GSK4527226 Dose 2
Participants will receive GSK4527226 Dose 2
Drug: GSK4527226
GSK4527226 will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score for Dose 1 vs Placebo Across Weeks 52, 64 and 76
Time Frame: Baseline, Week 52, 64 and 76
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 None=0, Questionable=0.5, Mild=1, Moderate=2, and Severe=3. The CDR-SB is obtained by adding the ratings in each of the 6 categories and ranges from 0 to 18 with higher scores indicative of greater impairment.
Baseline, Week 52, 64 and 76

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Score for Dose 1 vs Placebo Across Weeks 52, 64 and 76
Time Frame: Baseline, Weeks 52, 64 and 76
The iADRS is a composite score that measures both cognition and function. The iADRS comprises scores from the AD Assessment Scale-Cognitive subscale (ADAS-Cog) and the Alzheimers Disease Cooperative Study-instrumental Activities of Daily Living (ADCS-iADL). The iADRS is calculated as a linear combination of the total scores of the ADAS-Cog14 (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. Higher scores indicate greater impairment) and the ADCS-iADL (score range from 0-49 with higher scores reflecting better performance and lower scores indicating greater functional impairment).
Baseline, Weeks 52, 64 and 76
Change from Baseline in ADAS-Cog14 Score for Dose 1 vs Placebo Across Weeks 52, 64 and 76
Time Frame: Baseline, Weeks 52, 64 and 76
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. Score ranges from 0 to 90 and higher scores indicate greater impairment.
Baseline, Weeks 52, 64 and 76
Change from Baseline in ADCS-ADL-MCI Score for Dose 1 vs Placebo Across Weeks 52, 64 and 76
Time Frame: Baseline, Weeks 52, 64 and 76
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, Weeks 52, 64 and 76
Change from Baseline in ADCS-iADL component of ADCS-ADL-MCI Score for Dose 1 vs Placebo Across Weeks 52, 64 and 76
Time Frame: Baseline, Weeks 52, 64 and 76
The ADCS-iADL is a subscale which measures instrumental activities of daily living. The ADCS-iADL is derived from the ADCS-ADL-MCI. It has a total score ranging from 0 to 49 with lower scores indicating greater functional impairment.
Baseline, Weeks 52, 64 and 76
Change from Baseline in Alzheimer's Disease Composite Score (ADCOMS) for Dose 1 vs Placebo Across Weeks 52, 64 and 76
Time Frame: Baseline, Weeks 52, 64 and 76
The ADCOMS is a composite score comprising scores from various items of the Mini-Mental Status Examination (MMSE), ADAS-Cog14, and CDR domains. 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. It assesses orientation (time and place), registration, attention and calculation, recent memory, language (naming, comprehension, and repetition), and constructional praxis (copying a figure). For ADCOMS a higher score is indicative of greater impairment.
Baseline, Weeks 52, 64 and 76

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Collaborators

Alector Inc.

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2023

Primary Completion (Estimated)

December 2, 2026

Study Completion (Estimated)

May 16, 2029

Study Registration Dates

First Submitted

October 6, 2023

First Submitted That Met QC Criteria

October 6, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 219867
  • 2023-505083-11-00 (Other Identifier: EU CTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

IPD Sharing Time Frame

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 terminated asset(s) across all indications.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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