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NCT03635047 · ClinicalTrials.gov registry record · Phase 1

A Phase I Study for Safety and Tolerability of AL002.

A Phase 1 study of Healthy and Alzheimer Disease, sponsored by Alector.

Completed
Registry status
Phase 1
Development phase
69
Enrollment target
6
Study locations

NCT03635047 is a Phase 1 study of Healthy and Alzheimer Disease that has completed, run by Alector. The registered enrollment target is 69 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (89% lower). The trial reports 6 study locations across 3 states.

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The verdict

NCT03635047, a Phase 1 study of Healthy and Alzheimer Disease, has completed, sponsored by Alector.

COMPLETED
Registry status
Phase 1
Development phase
69 participants
Enrollment target
6
Study locations

Study 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.

Interventions

  • OTHER Saline Solution
  • BIOLOGICAL AL002

Study Locations (6)

Florida

  • Brain Matters Research - Delray Beach
  • Compass Research - Orlando - Orlando
  • Compass Research - The Villages - The Villages

Other

  • Nucleus Network Pty Ltd - Melbourne
  • University College London - London

New York

  • Columbia University - New York

Trial Details

FieldValue
Enrollment Target 69 participants
Start Date 2018-11-12
Est. Completion 2020-11-25
Phase Phase 1

Sponsor

Alector

10 total trials

What the Registry Record Tells You About NCT03635047

The ClinicalTrials.gov registry entry for NCT03635047 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (89% lower). The listed sponsor is Alector, which has 10 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Saline Solution is the first listed.

NCT03635047 reports 6 study locations spanning 3 distinct geographic areas - top geographies include Florida, Other, New York.

Frequently Asked Questions

What is clinical trial NCT03635047 about?

NCT03635047 is a clinical study titled "A Phase I Study for Safety and Tolerability of AL002.". 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, pharmac...

What is the current status of trial NCT03635047?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 69 participants. The study started on 2018-11-12. Estimated completion is 2020-11-25.

What conditions does trial NCT03635047 study?

This clinical trial studies the following conditions: Healthy, Alzheimer Disease.

What interventions are being tested in trial NCT03635047?

The interventions under investigation include: Saline Solution (OTHER), AL002 (BIOLOGICAL).

Who is sponsoring clinical trial NCT03635047?

This trial is sponsored by Alector, which has 10 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03635047 being conducted?

This trial has 6 study locations across Florida, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.