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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

Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 22 Jul 2020

At a glance

  • Drugs AL-002 (Primary)
  • Indications Alzheimer's disease
  • Focus Adverse reactions; First in man
  • Acronyms INVOKE
  • Sponsors Alector
  • Most Recent Events

    • 07 Jul 2020 Planned End Date changed from 1 Mar 2020 to 1 Nov 2020.
    • 07 Jul 2020 Planned primary completion date changed from 1 Dec 2019 to 1 Sep 2020.
    • 07 Jul 2020 Status changed from recruiting to active, no longer recruiting.

Trial Overview

Purpose

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.

Primary Endpoints

Evaluation of safety and tolerability of AL002 measured by number of subjects with adverse events and Dose Limiting Adverse Event (DLAEs)

description: Incidence of adverse events and dose limiting Adverse Events during the DLAE observation period and/or study treatment periods.
time_frame: 141 days

Other Endpoints

Pharmacokinetics (PK) of AL002

description: Serum and CSF concentration of AL002 at specified time points
time_frame: 85 days

Maximum plasma concentration (Cmax) for AL002

description: Evaluate Cmax for serum and CSF concentration of AL002 at specified time points
time_frame: 85 days

Area under the curve concentration (AUC) for AL002

description: Evaluate AUC for serum and CSF concentration of AL002 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: 67

    Actual: 69

  • 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 [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.

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
NCT03635047 ClinicalTrials.gov: US National Institutes of Health
AL002-1 -

Organisations

  • Sponsors Alector
  • Affiliations Alector

Trial Dates

  • Initiation Dates

    Planned : 01 Nov 2018

    Actual : 12 Nov 2018

  • Primary Completion Dates

    Planned : 01 Sep 2020

  • End Dates

    Planned : 01 Nov 2020

Other Details

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

Interventions

Drugs Route Formulation
AL-002Primary Drug Intravenous Infusion

AL002

AL002 by intravenous (IV) infusion Biological: AL002 (Single-doses of AL002 in up to 9 dose-escalating cohorts)

Saline Solution

placebo by intravenous (IV) infusion Other: 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)

Results

Publications

  1. Alector. Alector Announces Publication of Preclinical and Phase 1 Data Validating Potential of AL002, a TREM2 Activating Antibody for the Treatment of Alzheimers Disease, in The Journal of Experimental Medicine. Media-Rel 2020;.

    Media Release

Authors

Author Total Publications First Author Last Author
Alector 1 1 1

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Ben Snyder Nucleus Network
-
Study Coordinator Alfred Health, Bioclinica Research - Orlando, Bioclinica Research - The Villages, Box Hill Hospital, Nucleus Network Pty Ltd, University College London Australia, United-Kingdom, USA
Study Lead
Telephone: 415-231-5660 Ext. 329
Email: madeline.spencer@alector.com
show details
Alector Inc.
-

Centres

Centre Name Location Trial Centre Country
Alector Inc.
-
-
Alfred Health Melbourne Australia
Bioclinica Research - Orlando Orlando, Florida USA
Bioclinica Research - The Villages The Villages, Florida USA
Box Hill Hospital Melbourne Australia
Nucleus Network
-
-
Nucleus Network Pty Ltd Melbourne Australia
University College London London United-Kingdom

Trial History

Event Date Event Type Comment
22 Jul 2020 Other trial event Last checked against the ClinicalTrials.gov record. Updated 22 Jul 2020
07 Jul 2020 Completion date Planned End Date changed from 1 Mar 2020 to 1 Nov 2020. Updated 14 Jul 2020
07 Jul 2020 Other trial event Planned primary completion date changed from 1 Dec 2019 to 1 Sep 2020. Updated 14 Jul 2020
07 Jul 2020 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting. Updated 14 Jul 2020
25 Jun 2020 Status change - completed Status changed from recruiting to completed, according to an Alector media release. Updated 02 Jul 2020
25 Jun 2020 Interim results Interim Results (n=56) published in an Alector Media Release. Updated 02 Jul 2020
25 Jun 2020 Interim results According to an Alector media release, preliminary Phase 1 clinical data (n=56) of AL002 published in The Journal of Experimental Medicine. Updated 02 Jul 2020
28 Jan 2019 Other trial event Planned number of patients changed from 52 to 67. Updated 06 Feb 2019
15 Nov 2018 Status change - recruiting Status changed from not yet recruiting to recruiting, according to an Alector media release. Updated 02 Jan 2019
23 Aug 2018 New trial record New trial record Updated 23 Aug 2018

References

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

    Available from: URL: http://clinicaltrials.gov
  2. Alector. Alector Initiates Phase 1 Trial of AL002 for the Treatment of Patients with Alzheimer's Disease. Media-Rel 2018;.

    Media Release
  3. Alector. Alector Announces Publication of Preclinical and Phase 1 Data Validating Potential of AL002, a TREM2 Activating Antibody for the Treatment of Alzheimers Disease, in The Journal of Experimental Medicine. Media-Rel 2020;.

    Media Release
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