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

Alector

Status and phase: Active, not recruiting; Phase 2

Conditions: Alzheimer Disease

Treatments: Drug: Placebo; Drug: AL002

Study type: Interventional

Funder types: Industry

Identifiers

NCT04592874

AL002-2

Details and patient eligibility

About

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

Full description

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.

Enrollment: 328 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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328 participants in 4 patient groups, including a placebo group

AL002 Dose 1

Experimental group

Description:

AL002 every 4 weeks

Treatment:

Drug: AL002

AL002 Dose 2

Experimental group

Description:

AL002 every 4 weeks

Treatment:

Drug: AL002

AL002 Dose 3

Experimental group

Description:

AL002 every 4 weeks

Treatment:

Drug: AL002

Placebo

Placebo Comparator group

Description:

Placebo every 4 weeks

Treatment:

Drug: Placebo