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

Alector Inc.356 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

356

Conditions

Alzheimer Disease

Interventions

AL002DRUG

Administered via intravenous (IV) infusion

PlaceboDRUG

Administered via intravenous (IV) infusion

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (87)

Outcomes

Primary Outcomes

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.

Time frame: Study completion up to 96 weeks

Secondary Outcomes

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.

Time frame: Study completion up to 96 weeks

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.

Time frame: Study completion up to 96 weeks

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.

Data from ClinicalTrials.gov

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