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NCT03636204 · ClinicalTrials.gov registry record · Phase 1

A First in Human Study in Healthy Volunteers and in Participants With Frontotemporal Dementia With Granulin (GRN) Mutation

A Phase 1 study of Healthy and Frontotemporal Dementia, sponsored by Alector.

Completed
Registry status
Phase 1
Development phase
64
Enrollment target
8
Study locations

NCT03636204 is a Phase 1 study of Healthy and Frontotemporal Dementia that has completed, run by Alector. The registered enrollment target is 64 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (90% lower). The trial reports 8 study locations across 7 states.

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The verdict

NCT03636204, a Phase 1 study of Healthy and Frontotemporal Dementia, has completed, sponsored by Alector.

COMPLETED
Registry status
Phase 1
Development phase
64 participants
Enrollment target
8
Study locations

Study Summary

A first in human phase 1 study in healthy volunteers and participants with Granulin (GRN) mutation causative of frontotemporal dementia (FTD) to assess AL001 safety, tolerability, pharmacokinetics, and pharmacodynamics

Interventions

  • OTHER Placebo
  • BIOLOGICAL AL001

Study Locations (8)

Other

  • Sunnybrook Health Sciences Centre - Toronto
  • University College London - London

Alabama

  • University of Alabama - Birmingham

California

  • UCSF - San Francisco

Florida

  • Study site - Orlando

Minnesota

  • Mayo Clinic - Rochester

Pennsylvania

  • University of Pennsylvania - Philadelphia

Ontario

  • Lawson Health Research Institute, St. Joseph's - London

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2018-09-14
Est. Completion 2019-12-31
Phase Phase 1

Sponsor

Alector

10 total trials

What the Registry Record Tells You About NCT03636204

The ClinicalTrials.gov registry entry for NCT03636204 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 64 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 (90% 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 Placebo is the first listed.

NCT03636204 reports 8 study locations spanning 7 distinct geographic areas - top geographies include Other, Alabama, California.

Frequently Asked Questions

What is clinical trial NCT03636204 about?

NCT03636204 is a clinical study titled "A First in Human Study in Healthy Volunteers and in Participants With Frontotemporal Dementia With Granulin (GRN) Mutation". A first in human phase 1 study in healthy volunteers and participants with Granulin (GRN) mutation causative of frontotemporal dementia (FTD) to assess AL001 safety, tolerability, pharmacokinetics, and pharmacodynamics

What is the current status of trial NCT03636204?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2018-09-14. Estimated completion is 2019-12-31.

What conditions does trial NCT03636204 study?

This clinical trial studies the following conditions: Healthy, Frontotemporal Dementia.

What interventions are being tested in trial NCT03636204?

The interventions under investigation include: Placebo (OTHER), AL001 (BIOLOGICAL).

Who is sponsoring clinical trial NCT03636204?

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

Where is trial NCT03636204 being conducted?

This trial has 8 study locations across Alabama, California, Florida, Minnesota, Pennsylvania. 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 Editorial

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.