Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
69 participants
INTERVENTIONAL
2018-11-12
2020-11-25
Brief Summary
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Detailed Description
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In the single ascending dose (SAD) phase up to approximately 56 healthy adult participants will be sequentially enrolled into up to approximately 9 cohorts In the multiple-dose (MD) phase, approximately 32 patients with mild to moderate Alzheimer's disease will be enrolled in three cohorts.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AL002
AL002 by intravenous (IV) infusion
AL002
Single-doses of AL002 in up to 9 dose-escalating cohorts
Saline Solution
placebo by intravenous (IV) infusion
Saline Solution
Saline solution will be administered as a single infusion for each cohort in a ratio of 6 active and 2 placebo subjects for HV and 10 active and 2 placebo for patients
Interventions
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AL002
Single-doses of AL002 in up to 9 dose-escalating cohorts
Saline Solution
Saline solution will be administered as a single infusion for each cohort in a ratio of 6 active and 2 placebo subjects for HV and 10 active and 2 placebo for patients
Eligibility Criteria
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Inclusion Criteria
2. Clinical laboratory evaluations (including chemistry panel fasted \[fasted at least 8 hours\], complete blood count (CBC), and urine analysis) within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator. A count of the segmented neutrophils and bands should be performed when results from the white blood cells (WBCs) are not within the reference range.
3. Negative test for selected drugs of abuse at screening (does not include alcohol) and at admission (testing at admission does include alcohol breath test). A positive result may be verified by re-testing (up to one false positive result permitted) and may be followed up at the discretion of the Investigator.
4. Females must be non-pregnant and non-lactating, and either surgically sterile
5. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), laboratory tests, and vital signs.
For MD cohort
1. Ages 50-85 years, inclusive.
2. The participant should be capable of completing assessments alone, per local guidelines.
3. Availability of a person ("study partner") who, in the Investigator's judgment, has frequent and sufficient contact with the participant and is able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to provide information at clinic visits, which require partner input for scale completion, and signs the necessary consent form, per local guidelines.
4. Clinical diagnosis of probable Alzheimer's disease dementia based on National Institute on Aging Alzheimer's Association criteria.
Exclusion Criteria
2. Participation in a clinical trial within 30 days before randomization; use of any experimental oral therapy within 30 days or 5 half-lives prior to Day 1, whichever is greater; or use of any biologic therapy within 12 weeks or 5 half-lives prior to Day 1, whichever is greater. Participants who have received an experimental therapy that has no half-life, like a vaccine, should have completed that therapy at least 12 weeks prior to Day 1. Participants who have received an experimental vaccine against a central nervous system (CNS) target, such as beta-amyloid or tau, are not eligible for this study.
3. Any non-experimental vaccine within 2 weeks of randomization, until 2 weeks after the last dose. It is advised that prospective participants receive their annual influenza vaccine as early as possible in advance of the flu season, and then wait 2 weeks prior to randomization. It is permitted to receive the annual influenza vaccine during the screening period.
4. Surgery or hospitalization during the 4 weeks prior to screening.
5. Planned procedure or surgery during the study.
6. Systemically, clinically significantly immunocompromised patients, owing to continuing effects of immune suppressing medication.
7. Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
8. Past history of seizures, with the exception of childhood febrile seizures.
18 Years
85 Years
ALL
Yes
Sponsors
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Alector Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Paul, MD
Role: STUDY_DIRECTOR
Alector Inc.
Locations
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Brain Matters Research
Delray Beach, Florida, United States
Compass Research - Orlando
Orlando, Florida, United States
Compass Research - The Villages
The Villages, Florida, United States
Columbia University
New York, New York, United States
Nucleus Network Pty Ltd
Melbourne, , Australia
University College London
London, , United Kingdom
Countries
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References
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Long H, Simmons A, Mayorga A, Burgess B, Nguyen T, Budda B, Rychkova A, Rhinn H, Tassi I, Ward M, Yeh F, Schwabe T, Paul R, Kenkare-Mitra S, Rosenthal A. Preclinical and first-in-human evaluation of AL002, a novel TREM2 agonistic antibody for Alzheimer's disease. Alzheimers Res Ther. 2024 Oct 23;16(1):235. doi: 10.1186/s13195-024-01599-1.
Other Identifiers
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AL002-1
Identifier Type: -
Identifier Source: org_study_id