A Phase 2 Study to Evaluate Efficacy and Safety of AL002... | NCT04592874

Label	Type	Description	Intervention Names
AL002 Dose 1	Experimental	AL002 every 4 weeks	Drug: AL002
AL002 Dose 2	Experimental	AL002 every 4 weeks	Drug: AL002
AL002 Dose 3	Experimental	AL002 every 4 weeks	Drug: AL002
Placebo	Placebo Comparator	Placebo every 4 weeks	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
AL002	Drug	Administered via intravenous (IV) infusion	AL002 Dose 1 AL002 Dose 2 AL002 Dose 3

Measure	Description	Time Frame
Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score	Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) score at Weeks 24, 48, 72 and 96. The CDR-SB is a tool used to measure disease severity in Alzheimer's disease. This scale assesses three domains of cognition and three domains of function. The domains are rated on a 5 point scale in which the higher the score corresponds to greater cognitive impairment. The scale range is from 0 to 18 where 0 is considered normal and 18 indicates severe dementia.	Study completion up to 96 weeks

Measure	Description	Time Frame
Change in Mini-Mental Status Examination (MMSE) Score	Change from baseline in Mini-Mental Status Examination (MMSE) score at Weeks 24, 48, 72, and 96 The MMSE is a test that assesses orientation, registration, attention and calculation, recent memory, language and constructional praxis. There is a total possible score of 30 with a lower score correlating to a higher cognitive impairment. A score of 24 to 30 is considered normal or no cognitive impairment. A score of 18 to 24 indicates mild impairment. A score of 0 to 17 indicates a severe impairment.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of Early AD including evidence of brain amyloidosis by CSF or PET
MMSE score ≥ 20 points, CDR Global Score of 0.5 - 1.0, and RBANS score on the DMI ≤95.
Study partner who consents to study participation and who cares for/visits the participant at least 10 hours a week
Written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker).

Exclusion Criteria:

Dementia due to a condition other than AD including, but not limited to, FTD, Parkinson's disease, dementia with Lewy bodies, Huntington disease, or vascular dementia.
Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
Current uncontrolled hypertension, diabetes mellitus or thyroid disease. Clinically significant heart disease, liver disease or kidney disease.
History or evidence of clinically significant brain disease other than AD.
Females who are pregnant or breastfeeding, or planning to conceive within the study period.
Any experimental vaccine or gene therapy.
History of unresolved cancer.
Current use of anticoagulant medications.
Residence in a skilled nursing facility, convalescent home, or long term care facility at screening; or requires continuous nursing care.
Participant is positive for presence of APOE e4/e4 genotype.

Name	Affiliation	Role
Catherine Mummery		Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Banner Alzheimer's Institute		Phoenix	Arizona	85006	United States
Woodlands Research Network, LLC - ERG

PubMed Identifier	Type	Citation	Retractions
41787076	Derived	Mummery CJ, Mayorga AJ, Simmons A, Chow TW, Burgess B, Nguyen T, Gao J, Budda B, Park LQ, Gupta R, Li C, Shi L, Kenkare-Mitra S, Rosenthal A, Paul R, Ward M, Purcell DD, Salloway S, Grundman M, Romano G, Salvadore G. The TREM2 agonistic antibody AL002 in early Alzheimer's disease: a phase 2 randomized trial. Nat Med. 2026 May;32(5):1708-1716. doi: 10.1038/s41591-026-04273-1. Epub 2026 Mar 5.
40145953

ID	Title	Description
FG000	AL002 Dose 1: 15 mg/kg	AL002 every 4 weeks
FG001	AL002 Dose 2: 40 mg/kg	AL002 every 4 weeks

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 20, 2023	Aug 13, 2025

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score

Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) score at Weeks 24, 48, 72 and 96.

The CDR-SB is a tool used to measure disease severity in Alzheimer's disease. This scale assesses three domains of cognition and three domains of function. The domains are rated on a 5 point scale in which the higher the score corresponds to greater cognitive impairment. The scale range is from 0 to 18 where 0 is considered normal and 18 indicates severe dementia.

Adult participants with early Alzheimer's Disease excluding apolipoprotein E homozygotes

Posted

Least Squares Mean

Standard Error

Score on a scale

Study completion up to 96 weeks

ID	Title	Description
OG000	AL002 Dose 1: 15 mg/kg	AL002 every 4 weeks
OG001	AL002 Dose 2: 40 mg/kg	AL002 every 4 weeks
OG002	AL002 Dose 3: 60 mg/kg	AL002 every 4 weeks
OG003	Placebo	Placebo every 4 weeks

Units	Counts
Participants	OG00089 OG00187 OG00292 OG003

Title	Denominators	Categories
Week 24 Change from Baseline	ParticipantsOG00066 ParticipantsOG00173 ParticipantsOG00268 ParticipantsOG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG002 OG003	This is using the Week 96 timepoint	Mixed Models Analysis		0.7975		Mean Difference (Final Values)	-0.17			2-Sided	95	-1.49	1.15					Superiority
OG000 OG003	This is using the Week 96 timepoint	Mixed Models Analysis

Secondary

Change in Mini-Mental Status Examination (MMSE) Score

Change from baseline in Mini-Mental Status Examination (MMSE) score at Weeks 24, 48, 72, and 96

The MMSE is a test that assesses orientation, registration, attention and calculation, recent memory, language and constructional praxis. There is a total possible score of 30 with a lower score correlating to a higher cognitive impairment. A score of 24 to 30 is considered normal or no cognitive impairment. A score of 18 to 24 indicates mild impairment. A score of 0 to 17 indicates a severe impairment.

Adult participants with early Alzheimer's Disease excluding apolipoprotein E homozygotes

Posted

Least Squares Mean

Standard Error

Score on a scale

Study completion up to 96 weeks

ID	Title	Description
OG000	AL002 Dose 1: 15 mg/kg	AL002 every 4 weeks
OG001	AL002 Dose 2: 40 mg/kg	AL002 every 4 weeks
OG002	AL002 Dose 3: 60 mg/kg	AL002 every 4 weeks
OG003	Placebo	Placebo every 4 weeks

Secondary

Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score

Change from baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score at Weeks 24, 48, 72 and 96

The RBANS test is a collection of 12 subsets representing 5 neurological domains: immediate memory, visuospatial/constructional, language, attention, and delayed memory. The scores are converted to a scale that can range from 40 to 160. The lower the score the greater the cognitive impairment.

Adult participants with early Alzheimer's Disease excluding apolipoprotein E homozygotes

Posted

Least Squares Mean

Standard Error

Score on a scale

Study completion up to 96 weeks

ID	Title	Description
OG000	AL002 Dose 1: 15 mg/kg	AL002 every 4 weeks
OG001	AL002 Dose 2: 40 mg/kg	AL002 every 4 weeks
OG002	AL002 Dose 3: 60 mg/kg	AL002 every 4 weeks
OG003	Placebo	Placebo every 4 weeks

Secondary

Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score

Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) score at Weeks 24, 48, 72, and 96

The ADAS-Cog13 is a scale that includes 13 items to assess cognitive function. These domains include memory, language, praxis, and orientation, as well as a number cancellation task and a delayed free recall task. There is a total score range of 0 to 85. A higher score on this scale indicates greater cognitive impairment. There are currently no universally accepted severity bands for ADAS-Cog13 as it is used to track changes in disease and not for severity.

Adult participants with early Alzheimer's Disease excluding apolipoprotein E homozygotes

Posted

Least Squares Mean

Standard Error

Score on a scale

Study completion up to 96 weeks

ID	Title	Description
OG000	AL002 Dose 1: 15 mg/kg	AL002 every 4 weeks
OG001	AL002 Dose 2: 40 mg/kg	AL002 every 4 weeks
OG002	AL002 Dose 3: 60 mg/kg	AL002 every 4 weeks
OG003	Placebo

Secondary

Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL-MCI) Score

Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL-MCI) score at Weeks 24, 48, 72, and 96

The ADCS-ADL-MCI is a scale for participants with mild cognitive impairment that observes their performance in completing activities associated with daily living. This scale is a multiple choice questionnaire and has a range of 0 to 53. A lower score on this scale indicates greater cognitive impairment.

Adult participants with early Alzheimer's Disease excluding apolipoprotein E homozygotes

Posted

Least Squares Mean

Standard Error

Score on a scale

Study completion up to 96 weeks

ID	Title	Description
OG000	AL002 Dose 1: 15 mg/kg	AL002 every 4 weeks
OG001	AL002 Dose 2: 40 mg/kg	AL002 every 4 weeks
OG002	AL002 Dose 3: 60 mg/kg	AL002 every 4 weeks
OG003	Placebo

Secondary

Change in Alzheimer's Disease Composite Score (ADCOMS) Score

Change from baseline in Alzheimer's Disease Composite Score (ADCOMS) score at Weeks 24, 48, 72, and 96

The ADCOMS scale is a composite score of 12 components that include 4 items from the ADAS-Cog13, 2 items from the MMSE, and all 6 items from the CDR-SB scales. The range of the ADCOMS is between 0 and 1.97. The higher the score the greater the cognitive impairment.

Adult participants with early Alzheimer's Disease excluding apolipoprotein E homozygotes

Posted

Least Squares Mean

Standard Error

Score on a scale

Study completion up to 96 weeks

ID	Title	Description
OG000	AL002 Dose 1: 15 mg/kg	AL002 every 4 weeks
OG001	AL002 Dose 2: 40 mg/kg	AL002 every 4 weeks
OG002	AL002 Dose 3: 60 mg/kg	AL002 every 4 weeks
OG003	Placebo	Placebo every 4 weeks

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 27.1	Systematic Assessment	EG0000 affected97 at risk EG0011 affected94 at risk EG0020 affected77 at risk EG0030 affected88 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 27.1	Systematic Assessment	EG0000 affected97 at risk EG0011 affected94 at risk EG0020 affected77 at risk EG003
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 27.1	Systematic Assessment	EG0001 affected97 at risk EG0010 affected94 at risk EG0020 affected77 at risk EG003
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 27.1	Systematic Assessment	EG0000 affected97 at risk EG0011 affected94 at risk EG0020 affected77 at risk EG003
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 27.1	Systematic Assessment	EG0000 affected97 at risk EG0010 affected94 at risk EG0020 affected77 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 affected97 at risk EG0011 affected94 at risk EG0020 affected77 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA Version 27.1	Systematic Assessment	EG0002 affected97 at risk EG0010 affected94 at risk EG0021 affected77 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 affected97 at risk EG0010 affected94 at risk EG0020 affected77 at risk EG003
Confusional state	Psychiatric disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 affected97 at risk EG0011 affected94 at risk EG0020 affected77 at risk EG003
Aggression	Psychiatric disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 affected97 at risk EG0010 affected94 at risk EG0021 affected77 at risk EG003
Joint injury	Injury, poisoning and procedural complications	MedDRA Version 27.1	Systematic Assessment	EG0000 affected97 at risk EG0011 affected94 at risk EG0020 affected77 at risk EG003
Limb traumatic amputation	Injury, poisoning and procedural complications	MedDRA Version 27.1	Systematic Assessment	EG0000 affected97 at risk EG0010 affected94 at risk EG0021 affected77 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA Version 27.1	Systematic Assessment	EG0000 affected97 at risk EG0010 affected94 at risk EG0021 affected77 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA Version 27.1	Systematic Assessment	EG0000 affected97 at risk EG0011 affected94 at risk EG0020 affected77 at risk EG003
Skin wound	Injury, poisoning and procedural complications	MedDRA Version 27.1	Systematic Assessment	EG0000 affected97 at risk EG0010 affected94 at risk EG0021 affected77 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA Version 27.1	Systematic Assessment	EG0000 affected97 at risk EG0010 affected94 at risk EG0020 affected77 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA Version 27.1	Systematic Assessment	EG0000 affected97 at risk EG0010 affected94 at risk EG0020 affected77 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 affected97 at risk EG0010 affected94 at risk EG0020 affected77 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 affected97 at risk EG0010 affected94 at risk EG0020 affected77 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 affected97 at risk EG0010 affected94 at risk EG0020 affected77 at risk EG003
Syncope	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 affected97 at risk EG0011 affected94 at risk EG0021 affected77 at risk EG003
Amyloid related imaging abnormality - edema/effusion	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 affected97 at risk EG0011 affected94 at risk EG0020 affected77 at risk EG003
Amyloid related imaging abnormality - microhaemorrhages and haemosiderin deposits	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 affected97 at risk EG0010 affected94 at risk EG0020 affected77 at risk EG003
Aphasia	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 affected97 at risk EG0010 affected94 at risk EG0020 affected77 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 affected97 at risk EG0010 affected94 at risk EG0020 affected77 at risk EG003
Dementia Alzheimer's type	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 affected97 at risk EG0010 affected94 at risk EG0021 affected77 at risk EG003
Epilepsy	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 affected97 at risk EG0011 affected94 at risk EG0020 affected77 at risk EG003
Headache	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 affected97 at risk EG0011 affected94 at risk EG0020 affected77 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 affected97 at risk EG0011 affected94 at risk EG0020 affected77 at risk EG003
Polyneuropathy	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 affected97 at risk EG0010 affected94 at risk EG0020 affected77 at risk EG003
Glaucoma	Eye disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 affected97 at risk EG0010 affected94 at risk EG0020 affected77 at risk EG003
Diverticular perforation	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 affected97 at risk EG0010 affected94 at risk EG0020 affected77 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 affected97 at risk EG0011 affected94 at risk EG0020 affected77 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 affected97 at risk EG0010 affected94 at risk EG0020 affected77 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 affected97 at risk EG0010 affected94 at risk EG0020 affected77 at risk EG003
Biliary obstruction	Hepatobiliary disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 affected97 at risk EG0011 affected94 at risk EG0020 affected77 at risk EG003
Jaundice	Hepatobiliary disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 affected97 at risk EG0010 affected94 at risk EG0020 affected77 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 affected97 at risk EG0010 affected94 at risk EG0020 affected77 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 affected97 at risk EG0010 affected94 at risk EG0021 affected77 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 affected97 at risk EG0010 affected94 at risk EG0021 affected77 at risk EG003
Colonic abscess	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0001 affected97 at risk EG0010 affected94 at risk EG0020 affected77 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 affected97 at risk EG0010 affected94 at risk EG0021 affected77 at risk EG003
Parotitis	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 affected97 at risk EG0011 affected94 at risk EG0020 affected77 at risk EG003
Pneumonia	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 affected97 at risk EG0010 affected94 at risk EG0021 affected77 at risk EG003
Sepsis	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 affected97 at risk EG0010 affected94 at risk EG0021 affected77 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0001 affected97 at risk EG0010 affected94 at risk EG0020 affected77 at risk EG003
Diverticulitis	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 affected97 at risk EG0010 affected94 at risk EG0020 affected77 at risk EG003
Escherichia bacteraemia	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0000 affected97 at risk EG0010 affected94 at risk EG0020 affected77 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 affected97 at risk EG0010 affected94 at risk EG0020 affected77 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 affected97 at risk EG0010 affected94 at risk EG0021 affected77 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Fall	Injury, poisoning and procedural complications	MedDRA Version 27.1	Systematic Assessment	EG0005 affected97 at risk EG00119 affected94 at risk EG0027 affected77 at risk EG00311 affected88 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA Version 27.1	Systematic Assessment	EG0002 affected97 at risk EG0019 affected94 at risk EG00210 affected77 at risk EG003
Hypertension	Vascular disorders	MedDRA Version 27.1	Systematic Assessment	EG0004 affected97 at risk EG0016 affected94 at risk EG0027 affected77 at risk EG003
Amyloid related imaging abnormality-microhaemorrages and haemosiderin deposits	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG00028 affected97 at risk EG00128 affected94 at risk EG00221 affected77 at risk EG003
Amyloid related imaging abnormality-edema/effusion	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG00021 affected97 at risk EG00122 affected94 at risk EG00217 affected77 at risk EG003
Headache	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG00010 affected97 at risk EG00113 affected94 at risk EG0024 affected77 at risk EG003
Dizziness	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0006 affected97 at risk EG0017 affected94 at risk EG0026 affected77 at risk EG003
Syncope	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 affected97 at risk EG0012 affected94 at risk EG0021 affected77 at risk EG003
Fatigue	General disorders	MedDRA Version 27.1	Systematic Assessment	EG0003 affected97 at risk EG0014 affected94 at risk EG0024 affected77 at risk EG003
Cataract	Eye disorders	MedDRA Version 27.1	Systematic Assessment	EG0007 affected97 at risk EG0016 affected94 at risk EG0027 affected77 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0006 affected97 at risk EG0018 affected94 at risk EG0027 affected77 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0005 affected97 at risk EG0016 affected94 at risk EG0029 affected77 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0006 affected97 at risk EG0014 affected94 at risk EG0021 affected77 at risk EG003
Confusional state	Psychiatric disorders	MedDRA Version 27.1	Systematic Assessment	EG0001 affected97 at risk EG0013 affected94 at risk EG0020 affected77 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG0005 affected97 at risk EG0013 affected94 at risk EG0023 affected77 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 27.1	Systematic Assessment	EG0003 affected97 at risk EG0013 affected94 at risk EG0023 affected77 at risk EG003
Covid-19	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG00011 affected97 at risk EG00112 affected94 at risk EG00213 affected77 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0006 affected97 at risk EG0012 affected94 at risk EG0025 affected77 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0003 affected97 at risk EG0015 affected94 at risk EG0025 affected77 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA Version 27.1	Systematic Assessment	EG0005 affected97 at risk EG0014 affected94 at risk EG0022 affected77 at risk EG003

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D024801	Tauopathies
D019636	Neurodegenerative Diseases
D019965	Neurocognitive Disorders
D001523	Mental Disorders

ID	Title	Description
BG000	AL002 Dose 1: 15 mg/kg	AL002 every 4 weeks
BG001	AL002 Dose 2: 40 mg/kg	AL002 every 4 weeks
BG002	AL002 Dose 3: 60 mg/kg	AL002 every 4 weeks
BG003	Placebo	Placebo every 4 weeks
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	AL002 Dose 1: 15 mg/kg	AL002 every 4 weeks	1	97	14	97	66	97
EG001	AL002 Dose 2: 40 mg/kg	AL002 every 4 weeks	1	94	12	94	75	94
EG002	AL002 Dose 3: 60 mg/kg	AL002 every 4 weeks	1	77	10	77	59	77
EG003	Placebo	Placebo every 4 weeks	1	88	7	88	64	88