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A Phase I Study for Safety and Tolerability of AL002. | Clinical Trials | Clareo Health

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A Phase I Study for Safety and Tolerability of AL002.

A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Doses of AL002 in Healthy Participants and in Participants With Mild to Moderate Alzheimer's Disease

NCT03635047•Alector Inc.

View on ClinicalTrials.gov

Summary

This is a multi-centre, randomized, double-blind, placebo-controlled, dose escalation first in human (FIH) study in healthy adults and in patients with mild to moderate Alzheimer's disease. The study is designed to systematically assess the safety (including immunogenicity) and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AL002.

Detailed Description

The study will be conducted in 2 phases: 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.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Total body weight between 50 and 120 kg, inclusive.
•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

•1. Pregnant or lactating, or intending to become pregnant within 16 weeks after last dose of study drug.
•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.

Locations (6)

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

Key Dates

Start Date

November 12, 2018

Primary Completion Date

August 3, 2020

Completion Date

November 25, 2020

Last Updated

December 9, 2020

Enrollment

ACTUAL participants

Conditions

HealthyAlzheimer Disease

Interventions

AL002

BIOLOGICAL

Saline Solution

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 9, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase I Study for Safety and Tolerability of AL002.

Inclusion Criteria

Exclusion Criteria

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