Phase 2
N=356
A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease
Alzheimer Disease
Bottom Line
View on ClinicalTrials.gov: NCT04592874 ↗Enrolled (actual)
356
Serious AEs
12.1%
Results posted
Oct 2025
Primary outcome: Primary: Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score — 1.02; 0.80; 1.07; 1.15 Score on a scale — p=0.7975
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AL002 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Alector Inc.
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score |
1.02; 0.80; 1.07; 1.15; 1.68; 1.61 | 0.7975 |
| SECONDARY Change in Mini-Mental Status Examination (MMSE) Score |
-2.70; -3.03; -2.78; -2.65; -4.06; -3.91 | 0.7417 |
| SECONDARY Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score |
-3.37; -2.34; -2.65; -3.05; -7.15; -6.13 | 0.7934 |
| SECONDARY Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score |
1.09; 3.04; 3.54; 1.93; 3.86; 6.06 | 0.6403 |
| SECONDARY Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL-MCI) Score |
-1.60; -0.99; -2.45; -0.67; -2.95; -3.11 | 0.7945 |
| SECONDARY Change in Alzheimer's Disease Composite Score (ADCOMS) Score |
0.11; 0.11; 0.14; 0.13; 0.19; 0.20 | 0.6458 |
Summary
A phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 in participants with Early Alzheimer's Disease.
Eligibility Criteria
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.
- 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.
Data sourced from ClinicalTrials.gov (NCT04592874). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.