The trial is taking place at:
U

University of California, San Francisco | UCSF Memory and Aging Center

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

A

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

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

Trial contacts and locations

92

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Central trial contact

Study Lead

Data sourced from clinicaltrials.gov

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