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

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

  • Alzheimer Disease

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

Georgetown University Medical Center
Washington, District of Columbia 20007
Contact:
Study Coordinator

More Details

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.