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A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03987295
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
Alector Inc.

Brief Summary:
A Phase 2 open label study evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AL001 in participants with a Granulin mutation or C9orf72 mutation causative of frontotemporal dementia.

Condition or disease Intervention/treatment Phase
Frontotemporal Dementia Drug: AL001 Phase 2

Detailed Description:
This is a Phase 2, multicenter, open label study evaluating the safety, tolerability, PK and PD of AL001 administered intravenously in participants with a Granulin mutation or C9orf72 mutation causative of frontotemporal dementia.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in Heterozygous Carriers of Granulin or C9orf72 Mutations Causative of Frontotemporal Dementia
Actual Study Start Date : September 27, 2019
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : November 30, 2021


Arm Intervention/treatment
Experimental: AL001
AL001 every 4 weeks for up to 96-weeks
Drug: AL001
administered via intravenous (IV) infusion once a month




Primary Outcome Measures :
  1. Evaluation of safety and tolerability of AL001: Incidence of adverse events [ Time Frame: 96 weeks ]
    Incidence of adverse events


Secondary Outcome Measures :
  1. Pharmacokinetics (PK) of AL001 [ Time Frame: 96 weeks ]
    Concentration of AL001 at specified time points

  2. Maximum plasma concentration (Cmax) for AL001 [ Time Frame: 96 weeks ]
    Evaluate Cmax for concentration of AL001 at specified time points

  3. Area under the curve concentration (AUC) for AL001 [ Time Frame: 96 weeks ]
    Evaluate AUC for concentration of AL001 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:   No
Criteria

Inclusion Criteria:

  • At screening, female participants must be nonpregnant and nonlactating
  • In good physical health on the basis of no clinically significant findings from medical history, physical examinations (PEs), laboratory tests, ECGs, and vital signs.
  • Participant is a carrier of a loss of function progranulin gene (GRN) mutation or carrier of a hexanucleotide repeat expansion C9orf72 mutation

Exclusion Criteria:

  • Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
  • History of alcohol abuse or substance abuse
  • Participant resides in a skilled nursing facility, convalescent home, or long term care facility

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): NCT03987295


Contacts
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Contact: Study Lead 4152315660 ext 372 info@alector.com

Locations
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United States, Alabama
University of Alabama Withdrawn
Birmingham, Alabama, United States, 35294
United States, California
UCSF Recruiting
San Francisco, California, United States, 94158
Contact: Study Coordinator    415-514-5745    lauren.fisher@ucsf.edu   
Contact: Study Coordinator    415-476-0671    hannah.wiest@ucsf.edu   
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Study Coordinator    507-293-5551    Forsberg.leah@mayo.edu   
Contact: Study Coordinator    507-284-9295    Nelson.Kevin1@mayo.edu   
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Study Coordinator    215-662-3596    Frewine.Ogbaselase@pennmedicine.upenn.edu   
Contact: Study Coordinator    215-662-3596    Vidya.Chenji@Pennmedicine.upenn.edu   
Canada, Ontario
Lawson Health Research Institute, St. Joseph's Recruiting
London, Ontario, Canada, N6A 4V2
Contact: Study Coordinator    +1-519-685-4292 ext 45635    Rokhsana.Mortuza@sjhc.london.on.ca   
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Study Coordinator    416-480-6100 ext 1620    Michael.comishen@sunnybrook.ca   
Germany
Technical University of Munich Recruiting
Munchen, Germany, 81675
Contact: Study Coordinator    49 89 4140 4276    Bianca.Bierschneider@mri.tum.de   
Contact: Study Coordinator    49 89 4140 4276    Julia.Graesel@mri.tum.de   
University of Ulm Recruiting
Ulm, Germany, 89081
Contact: Study Coordinator    0049 731 500 63099    karin.graf@uni-ulm.de   
Contact: Study Coordinator    0049 731 500 63099    sarah.straub@uni-ulm.de   
Italy
University of Brescia Recruiting
Brescia, Italy, 25123
Contact: Study Coordinator    39 345 457 4826    benussialberto@gmail.com   
Netherlands
Erasmus University Medical Center Recruiting
Rotterdam, Netherlands, 3015 GD
Contact: Study Coordinator    0031-6-50031924    a.eladdouti-elbelhajji@erasmusmc.nl   
Contact: Study Coordinator    0031-6-50008263    w.degroot.1@erasmusmc.nl   
United Kingdom
University College London Recruiting
London, United Kingdom, WC1N 3BG
Contact: Study Coordinator    +44 (0) 20 3448 3105    drctrialenquiries@ucl.ac.uk   
Contact: Study Coordinator    44 203 44 84536    joanna.irish@nhs.net   
Sponsors and Collaborators
Alector Inc.
Investigators
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Principal Investigator: Peter Ljubenkov, MD University of California, San Francisco
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Responsible Party: Alector Inc.
ClinicalTrials.gov Identifier: NCT03987295    
Other Study ID Numbers: AL001-2
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020

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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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Dementia
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Neurodegenerative Diseases
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms