Phase
Condition
Alzheimer's Disease
Dementia
Memory Loss
Treatment
GSK4527226
Placebo
Clinical Study ID
Ages 50-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
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:
MMSE score of between 21 and 29 points
CDR-global score (GS) of 0.5 to 1.0.
CDR Memory Box score greater than or equal to (≥) 0.5.
Participants with objective impairment in episodic memory as indicated by atleast 1 standard deviation below age-adjusted mean in the Wechsler MemoryScale-IV Logical Memory II (WMS-IV LMII)
If the participant is receiving symptomatic AD medications such as anAcetylcholinesterase inhibitor (AChEI) or memantine, the dosing regimen must havebeen stable for at least 12 weeks prior to screening and is not expected to changeduring study participation.
If the participant is receiving other medications for AD related symptoms orassociated conditions, the dosing regimen must have been stable for at least 4 weeksprior to screening and not expected to change during study participation. Symptomsmust be considered adequately and stably controlled by the investigator, withoutmarked 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 massindex (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 orbreastfeeding, and if of child-bearing potential follows contraception requirementsoutlined in the protocol
A male participant is eligible to participate if he follows contraceptionrequirements outlined in the protocol
Willing and able to give informed consent which includes compliance with therequirements and restrictions listed in the informed consent form (ICF).
Availability of an adult person who has frequent and sufficient contact with theparticipant is able to provide accurate information regarding the participant'scognitive and functional abilities, agrees to provide information at clinic visits,and signs the ICF of the study partner.
Exclusion
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 cognitivefunction.
History or presence of stroke within the past 1 year or recent transient ischemicattack 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 ofinfections that resulted in neurologic sequelae.
History of primary psychiatric diagnosis that the investigator considers mayinterfere 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 disorderwithin the past 2 years
Magnetic resonance imaging (MRI) evidence based on central read of:
>3 lacunar infarcts.
Stroke involving a major vascular territory, severe small vessel, or whitematter disease.
Any territorial /cortical/other infarct >1 cubic centimetre (cm^3).
White matter hyperintense lesions on the FLAIR sequence that correspond to anoverall Fazekas score of 3
>4 microhaemorrhages.
Any areas of superficial (leptomeningeal) hemosiderosis.
A single macro-hemorrhage greater than 10 millimetres (mm) at greatestdiameter.
Vasogenic edema.
Cerebral contusion, encephalomalacia, aneurysms, vascular malformations, orinfective lesions.
Space occupying lesions or brain tumors.
Significant cerebral vascular pathology
Hydrocephalus/Normal pressure hydrocephalus.
Other MRI findings contraindicating participation in the study such assubarachnoid hemorrhage.
History suggestive of exposure to, or past tuberculosis (TB) infection shouldundergo screening for TB disease.
Chronic active immune disorder requiring systemic immunosuppressive therapy within 6months prior to Screening.
Screening serum vitamin B12 concentration < Lower limit of normal (LLN) or in thelow 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 12weeks
History of cancer
Known history of severe allergic, anaphylactic, or other hypersensitivity reactionsto chimeric, human, or humanized antibodies or fusion proteins
Planned surgery during the study which requires general, spinal, or epiduralanesthesia that would take place during the study.
Known genetic predisposition for clotting disorder or hemorrhagic disease.
Key exclusionary medications include:
Antipsychotics, opiates/opioids, cannabinoids, hypnotics, antidepressants, moodstabilizers, or stimulants that are used on a chronic basis, are exclusionaryif not consistent with the following rule: treatment has to have been at astable dose for at least 4 weeks before screening and should remain stableduring 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, usedwithin 6 months before screening.
Anticoagulation medications within 90 days of screening and during the study
Systemic immunosuppressive therapy within 6 months before screening and duringthe study.
Study Design
Connect with a study center
GSK Investigational Site
Capital Federal, Buenos Aires C1428AQK
ArgentinaSite Not Available
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires C1431FWO
ArgentinaSite Not Available
GSK Investigational Site
Buenos Aires, C1425AGC
ArgentinaActive - Recruiting
GSK Investigational Site
Ciudad Autonoma De Bueno, C1056ABJ
ArgentinaActive - Recruiting
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, C1431FWO
ArgentinaActive - Recruiting
GSK Investigational Site
Camperdown, New South Wales 2050
AustraliaActive - Recruiting
GSK Investigational Site
Darlinghurst, New South Wales 2010
AustraliaActive - Recruiting
GSK Investigational Site
Kogarah, New South Wales 2217
AustraliaActive - Recruiting
GSK Investigational Site
Macquarie Park, New South Wales 2113
AustraliaActive - Recruiting
GSK Investigational Site
Gold Coast, Queensland 4222
AustraliaActive - Recruiting
GSK Investigational Site
Southport, Queensland 4222
AustraliaSite Not Available
GSK Investigational Site
Heidelberg, Victoria 3079
AustraliaActive - Recruiting
GSK Investigational Site
Ivanhoe, Victoria 3079
AustraliaSite Not Available
GSK Investigational Site
Nedlands, Western Australia 6009
AustraliaActive - Recruiting
GSK Investigational Site
Melbourne,
AustraliaActive - Recruiting
GSK Investigational Site
Ottawa, Ontario K1Z 1G3
CanadaActive - Recruiting
GSK Investigational Site
Peterborough, Ontario K9H 2P4
CanadaActive - Recruiting
GSK Investigational Site
Toronto, Ontario M3B 2S7
CanadaActive - Recruiting
GSK Investigational Site
Greenfield Park, Quebec J4V 2J2
CanadaActive - Recruiting
GSK Investigational Site
Greenfield-Park, Quebec J4V 2J2
CanadaSite Not Available
GSK Investigational Site
Sherbrooke, Quebec J1J 2G2
CanadaActive - Recruiting
GSK Investigational Site
Verdun, Quebec H4H 1R3
CanadaSite Not Available
GSK Investigational Site
Helsinki, 00180
FinlandActive - Recruiting
GSK Investigational Site
Kuopio, 70210
FinlandActive - Recruiting
GSK Investigational Site
Oulu, 90100
FinlandActive - Recruiting
GSK Investigational Site
Turku, 20520
FinlandActive - Recruiting
GSK Investigational Site
Bron, 69500
FranceActive - Recruiting
GSK Investigational Site
Lille Cedex, 59037
FranceActive - Recruiting
GSK Investigational Site
Nice, 06100
FranceActive - Recruiting
GSK Investigational Site
Paris, 75010
FranceActive - Recruiting
GSK Investigational Site
Saint-Herblain, 44093
FranceActive - Recruiting
GSK Investigational Site
Strasbourg, 67000
FranceActive - Recruiting
GSK Investigational Site
Toulouse, 31300
FranceActive - Recruiting
GSK Investigational Site
Villeurbanne, 69100
FranceActive - Recruiting
GSK Investigational Site
Erbach, 64711
GermanyActive - Recruiting
GSK Investigational Site
Koeln, 50935
GermanyActive - Recruiting
GSK Investigational Site
Muenchen, 80336
GermanyActive - Recruiting
GSK Investigational Site
Muenster, 48149
GermanyActive - Recruiting
GSK Investigational Site
Baggiovara, Modena 41126
ItalySite Not Available
GSK Investigational Site
Cefalù, Palermo 90015
ItalySite Not Available
GSK Investigational Site
Mondino, Pavia 27100
ItalySite Not Available
GSK Investigational Site
Brescia, 25123
ItalyActive - Recruiting
GSK Investigational Site
CefalU PA, 90015
ItalyActive - Recruiting
GSK Investigational Site
Genova, 16132
ItalyActive - Recruiting
GSK Investigational Site
Milano, 20133
ItalyActive - Recruiting
GSK Investigational Site
Modena, 41126
ItalyActive - Recruiting
GSK Investigational Site
Monza, 20900
ItalyActive - Recruiting
GSK Investigational Site
Palermo, 90127
ItalySite Not Available
GSK Investigational Site
Pavia, 27100
ItalyActive - Recruiting
GSK Investigational Site
Perugia, 06129
ItalyActive - Recruiting
GSK Investigational Site
Roma, 00179
ItalySite Not Available
GSK Investigational Site
Jung Gu, 400711
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Seoul, 04763
Korea, Republic ofActive - Recruiting
GSK Investigational Site
's-Hertogenbosch, 5223 LA
NetherlandsSite Not Available
GSK Investigational Site
Amsterdam, 1081 GN
NetherlandsActive - Recruiting
GSK Investigational Site
Den Bosch, 5223 LA
NetherlandsActive - Recruiting
GSK Investigational Site
Zwolle, 8025 AZ
NetherlandsActive - Recruiting
GSK Investigational Site
Bergen, 5009
NorwayActive - Recruiting
GSK Investigational Site
Drammen, N-3004
NorwaySite Not Available
GSK Investigational Site
Oslo, 0450
NorwayActive - Recruiting
GSK Investigational Site
Stavanger,
NorwayActive - Recruiting
GSK Investigational Site
Pozuelo De Alarcón, Madrid 28223
SpainSite Not Available
GSK Investigational Site
Barcelona, 08028
SpainActive - Recruiting
GSK Investigational Site
Getxo, 48993
SpainSite Not Available
GSK Investigational Site
Getxo - Vizcaya, 48993
SpainActive - Recruiting
GSK Investigational Site
Madrid, 28223
SpainActive - Recruiting
GSK Investigational Site
Pamplona, 31008
SpainActive - Recruiting
GSK Investigational Site
Salamanca, 37007
SpainActive - Recruiting
GSK Investigational Site
San Sebastian, 20009
SpainSite Not Available
GSK Investigational Site
Terrassa (Barcelona), 08221
SpainSite Not Available
GSK Investigational Site
Terrassa - Barcelona, 08221
SpainActive - Recruiting
GSK Investigational Site
Valencia, 46026
SpainActive - Recruiting
GSK Investigational Site
Goteborg, 431 41
SwedenActive - Recruiting
GSK Investigational Site
Jonkoping, SE-551 85
SwedenSite Not Available
GSK Investigational Site
Jönköping, SE-551 85
SwedenSite Not Available
GSK Investigational Site
Malmo, 21146
SwedenActive - Recruiting
GSK Investigational Site
Malmö, 21146
SwedenSite Not Available
GSK Investigational Site
Mölndal, 431 41
SwedenSite Not Available
GSK Investigational Site
Stockholm,
SwedenActive - Recruiting
GSK Investigational Site
Kaohsiung, 833
TaiwanActive - Recruiting
GSK Investigational Site
Tainan, 704
TaiwanActive - Recruiting
GSK Investigational Site
Taoyuan, 333
TaiwanSite Not Available
GSK Investigational Site
Tau-Yuan, 333
TaiwanActive - Recruiting
GSK Investigational Site
Ankara, 06230
TurkeyActive - Recruiting
GSK Investigational Site
Capa/Istanbul, 34093
TurkeySite Not Available
GSK Investigational Site
CapaIstanbul, 34093
TurkeyActive - Recruiting
GSK Investigational Site
Birmingham, B16 8LT
United KingdomActive - Recruiting
GSK Investigational Site
Bristol, BS32 4SY
United KingdomActive - Recruiting
GSK Investigational Site
Glasgow, ML1 4UF
United KingdomActive - Recruiting
GSK Investigational Site
London, W1G 8TA
United KingdomActive - Recruiting
GSK Investigational Site
Motherwell, ML1 4UF
United KingdomSite Not Available
GSK Investigational Site
San Diego, California 92103
United StatesCompleted
GSK Investigational Site
DeLand, Florida 32720
United StatesSite Not Available
GSK Investigational Site
Lake Mary, Florida 32720
United StatesCompleted
GSK Investigational Site
Lake Worth, Florida 33462
United StatesActive - Recruiting
GSK Investigational Site
Maitland, Florida 32752
United StatesActive - Recruiting
GSK Investigational Site
Miami, Florida 33176
United StatesActive - Recruiting
GSK Investigational Site
Orlando, Florida 32804
United StatesCompleted
GSK Investigational Site
Stuart, Florida 34997
United StatesActive - Recruiting
GSK Investigational Site
The Villages, Florida 32162
United StatesActive - Recruiting
GSK Investigational Site
Wellington, Florida 33414
United StatesSite Not Available
GSK Investigational Site
Decatur, Georgia 30030
United StatesCompleted
GSK Investigational Site
Elk Grove Village, Illinois 60007
United StatesActive - Recruiting
GSK Investigational Site
Wichita, Kansas 67207
United StatesSite Not Available
GSK Investigational Site
Chesterfield, Missouri 63005
United StatesActive - Recruiting
GSK Investigational Site
Toms River, New Jersey 08755
United StatesActive - Recruiting
GSK Investigational Site
West Long Branch, New Jersey 07764
United StatesActive - Recruiting
GSK Investigational Site
New York, New York 10016
United StatesSite Not Available
GSK Investigational Site
Staten Island, New York 10314
United StatesActive - Recruiting
GSK Investigational Site
Matthews, North Carolina 28105
United StatesActive - Recruiting
GSK Investigational Site
North Canton, Ohio 44720
United StatesCompleted
GSK Investigational Site
Oklahoma City, Oklahoma 73112
United StatesActive - Recruiting
GSK Investigational Site
Portland, Oregon 07210
United StatesActive - Recruiting
GSK Investigational Site
Charleston, South Carolina 29403
United StatesActive - Recruiting
GSK Investigational Site
Houston, Texas 77030
United StatesActive - Recruiting
GSK Investigational Site
Fairfax, Virginia 22031
United StatesActive - Recruiting
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