Summary

Eligibility
for people ages 50-85 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

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

Official Title

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

Details

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.

Keywords

Alzheimer Disease AL002 Dose 1 AL002 Dose 2 AL002 Dose 3

Eligibility

You can join if…

Open to people ages 50-85

  • Diagnosis of Early AD including evidence of brain amyloidosis by CSF or PET
  • MMSE score ≥ 22 points, CDR Global Score of 0.5 - 1.0, and RBANS score on the DMI ≤85.
  • 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).

You CAN'T join if...

  • 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.

Locations

  • UCSF Memory and Aging Center not yet accepting patients
    San Francisco California 94158 United States
  • ATP Clinical Research accepting new patients
    Costa Mesa California 92626 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alector Inc.
ID
NCT04592874
Phase
Phase 2
Study Type
Interventional
Last Updated