A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease

Study Overview
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Brief Summary
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A phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 in participants with Early Alzheimer's Disease.

Detailed Description
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This is a phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 administered intravenously in participants with Early Alzheimer's Disease.

Official Title
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A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Drug: AL002
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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. - 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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AL002 Dose 1<br>AL002 every 4 weeks | Drug: AL002<br>* Administered via intravenous (IV) infusion<br>|
| Experimental: AL002 Dose 2<br>AL002 every 4 weeks | Drug: AL002<br>* Administered via intravenous (IV) infusion<br>|
| Experimental: AL002 Dose 3<br>AL002 every 4 weeks | Drug: AL002<br>* Administered via intravenous (IV) infusion<br>|
| Placebo Comparator: Placebo<br>Placebo every 4 weeks | Drug: Placebo<br>* Administered via intravenous (IV) infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease progression as measured by the CDR-SB |  | Through study completion, up to 48 through 96 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in MMSE score |  | Through study completion, up to 48 through 96 weeks | 
| Change in RBANS score |  | Through study completion, up to 48 through 96 weeks | 
| Change in ADAS-Cog13 score |  | Through study completion, up to 48 through 96 weeks | 
| Change in ADCS-ADL-MCI score |  | Through study completion, up to 48 through 96 weeks | 
| Change in ADCOMS score |  | Through study completion, up to 48 through 96 weeks | 
| Evaluation of safety and tolerability of AL002: Incidence of adverse events | Incidence of adverse events | Through study completion, up to 48 through 96 weeks |