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 ≥ 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.
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
Arm | Description | Assigned Intervention |
---|---|---|
Experimental AL002 Dose 1 |
AL002 every 4 weeks |
|
Experimental AL002 Dose 2 |
AL002 every 4 weeks |
|
Experimental AL002 Dose 3 |
AL002 every 4 weeks |
|
Placebo Comparator Placebo |
Placebo every 4 weeks |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Alector Inc.
Study Contact
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.