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A Phase I Study for Safety and Tolerability of AL002.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03635047
Recruitment Status : Active, not recruiting
First Posted : August 17, 2018
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
Alector Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Alzheimer Disease Biological: AL002 Other: Saline Solution Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 12, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: AL002
AL002 by intravenous (IV) infusion
Biological: AL002
Single-doses of AL002 in up to 9 dose-escalating cohorts

Placebo Comparator: 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




Primary Outcome Measures :
  1. Evaluation of safety and tolerability of AL002 measured by number of subjects with adverse events and Dose Limiting Adverse Event (DLAEs) [ Time Frame: 141 days ]
    Incidence of adverse events and dose limiting Adverse Events during the DLAE observation period and/or study treatment periods.


Secondary Outcome Measures :
  1. Pharmacokinetics (PK) of AL002 [ Time Frame: 85 days ]
    Serum and CSF concentration of AL002 at specified time points

  2. Maximum plasma concentration (Cmax) for AL002 [ Time Frame: 85 days ]
    Evaluate Cmax for serum and CSF concentration of AL002 at specified time points

  3. Area under the curve concentration (AUC) for AL002 [ Time Frame: 85 days ]
    Evaluate AUC for serum and CSF concentration of AL002 at specified time points



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03635047


Locations
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United States, Florida
Brain Matters Research
Delray Beach, Florida, United States, 33445
Compass Research - Orlando
Orlando, Florida, United States, 32806
Compass Research - The Villages
The Villages, Florida, United States, 32162
United States, New York
Columbia University
New York, New York, United States, 10032
Australia
Nucleus Network Pty Ltd
Melbourne, Australia
United Kingdom
University College London
London, United Kingdom
Sponsors and Collaborators
Alector Inc.
Investigators
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Principal Investigator: Ben Snyder Nucleus Network
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Responsible Party: Alector Inc.
ClinicalTrials.gov Identifier: NCT03635047    
Other Study ID Numbers: AL002-1
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders