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A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Doses of AL003 in Healthy Participants and in Participants With Mild to Moderate Alzheimer's Disease.

Trial Profile

A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Doses of AL003 in Healthy Participants and in Participants With Mild to Moderate Alzheimer's Disease.

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 28 Jul 2020

At a glance

  • Drugs AL 003 (Primary)
  • Indications Alzheimer's disease
  • Focus Adverse reactions; First in man
  • Sponsors Alector
  • Most Recent Events

    • 23 Jul 2020 Time frame changed from 134 days to 141 days for safety and tolerability endpoint.
    • 23 Jul 2020 Planned End Date changed from 1 Jul 2020 to 1 Feb 2021.
    • 23 Jul 2020 Planned primary completion date changed from 1 Apr 2020 to 1 Dec 2020.

Trial Overview

Purpose

This is a multi-center, 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 AL003.

Primary Endpoints

Evaluation of safety and tolerability of AL003 measured by number of subjects with adverse events and dose limiting adverse events (DLAE)

description: Incidence of adverse events during the treatment and follow up periods through out the study.
time_frame: 141 days

Other Endpoints

Pharmacokinetics (PK) of AL003

description: Serum and CSF concentration of AL003 at specific time points
time_frame: 85 days

Maximum concentration (Cmax) for AL003

description: Evaluate Cmax for serum and CSF concentration of AL003 at specified time points
time_frame: 85 days

Area under the curve concentration (AUC) for AL003

description: Evaluate AUC for serum and CSF concentration of AL003 at specified time points
time_frame: 85 days [1]

Diseases Treated

Indication Qualifiers Patient Segments
Alzheimer's disease treatment mild, moderate

Subjects

  • Subject Type patients & volunteers
  • Number

    Planned: 54

  • Sex male & female
  • Age Group 18-85 years; adult; elderly

Patient Inclusion Criteria

1. Total body weight between 50 and 120 kg, inclusive 2. Clinical laboratory evaluations (including chemistry panel 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 (dose not include alcohol) and 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, using double barrier method or abstinence. 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.

Patient Exclusion Criteria

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

Trial Details

Identifiers

Identifier Owner
NCT03822208 ClinicalTrials.gov: US National Institutes of Health
AL003-1 -

Organisations

  • Sponsors Alector
  • Affiliations Alector

Trial Dates

  • Initiation Dates

    Planned : 01 Mar 2019

    Actual : 29 Mar 2019

  • Primary Completion Dates

    Planned : 01 Dec 2020

  • End Dates

    Planned : 01 Feb 2021

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • Phase of Trial Phase I
  • Location Australia; USA
  • Focus Adverse reactions; First in man

Interventions

Drugs Route Formulation
AL 003Primary Drug Intravenous Infusion

AL003 by intravenous (IV) infusion

Single-doses of AL003 in dose-escalating cohorts Multiple doses of AL003 in single cohort Biological: AL003 (Single-doses of AL003 in dose-escalating cohorts Multiple doses of AL003 in a single cohort)

Placebo by intravenous (IV) infusion

Matching saline solution will be administered for placebo subjects Other: Saline Solution (Saline Solution will be administered as a single infusion for each dose escalation cohort in a ratio of 6 active and 2 placebo and as multiple infusions in the single cohort in a ratio of 10 active and 2 placebo)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Study Coordinator Brain Matters Research, Charter Research, Columbia University, PPD Clinical Research Unit, Synexus AES USA
Study Lead
650-410-3155 info@alector.com
show details
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Centres

Centre Name Location Trial Centre Country
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-
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Alector Inc.
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Brain Matters Research Delray Beach, Florida USA
Charter Research Lady Lake, Florida USA
Columbia University New York, New York USA
Nucleus Network Melbourne Australia
PPD Clinical Research Unit Orlando, Florida USA
Synexus AES The Villages, Florida USA

Trial History

Event Date Event Type Comment
28 Jul 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 28 Jul 2020
23 Jul 2020 Protocol amendment Time frame changed from 134 days to 141 days for safety and tolerability endpoint. Updated 28 Jul 2020
23 Jul 2020 Completion date Planned End Date changed from 1 Jul 2020 to 1 Feb 2021. Updated 28 Jul 2020
23 Jul 2020 Other trial event Planned primary completion date changed from 1 Apr 2020 to 1 Dec 2020. Updated 28 Jul 2020
18 Apr 2019 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 22 Apr 2019
01 Feb 2019 New trial record New trial record Updated 01 Feb 2019

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
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