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Purpose

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

Condition

Eligibility

Eligible Ages
Between 50 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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).

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
AL002 Dose 1
AL002 every 4 weeks
  • Drug: AL002
    Administered via intravenous (IV) infusion
Experimental
AL002 Dose 2
AL002 every 4 weeks
  • Drug: AL002
    Administered via intravenous (IV) infusion
Experimental
AL002 Dose 3
AL002 every 4 weeks
  • Drug: AL002
    Administered via intravenous (IV) infusion
Placebo Comparator
Placebo
Placebo every 4 weeks
  • Drug: Placebo
    Administered via intravenous (IV) infusion

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536
Contact:
Study Coordinator

More Details

NCT ID
NCT04592874
Status
Recruiting
Sponsor
Alector Inc.

Study Contact

Study Lead
650-826-2454
clinicaltrials@alector.com

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.