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A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3)

Primary Purpose

Frontotemporal Dementia

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AL001
Placebo
Open label - AL001
Sponsored by
Alector Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frontotemporal Dementia

Eligibility Criteria

25 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Persons with a progranulin gene mutation and at risk of developing FTD symptoms as evidenced by a biomarker, or persons with a progranulin gene mutation and diagnosed with FTD.
  • If symptomatic, one or more of the criteria for the diagnosis of possible behavioral variant FTD, or a diagnosis of Primary Progressive Aphasia.
  • Study partner who consents to study participation and who cares for/visits the participant daily for at least 5 hours per week.
  • Written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker).

Exclusion Criteria:

  • Dementia due to a condition other than FTD including, but not limited to, Alzheimer's disease, Parkinson's disease, dementia with Lewy bodies, Huntington disease, or vascular dementia.
  • Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
  • Current uncontrolled hypertension, diabetes mellitus or thyroid disease. Clinically significant heart disease, liver disease or kidney disease. History or evidence of clinically significant brain disease other than FTD.
  • Females who are pregnant or breastfeeding, or planning to conceive within the study period.
  • Any experimental vaccine or gene therapy.
  • History of cancer within the last 5 years.
  • Current use of anticoagulant medications (e.g., coumadin, heparinoids, apixaban).
  • Residence in a skilled nursing facility, convalescent home, or long term care facility at screening; or requires continuous nursing care.

Sites / Locations

  • Dignity HealthRecruiting
  • University of California San DiegoRecruiting
  • University of Colorado
  • University of Miami Medical CenterRecruiting
  • Emory UniversityRecruiting
  • Northwestern UniversityRecruiting
  • Indiana University Health Neuroscience CenterRecruiting
  • University of Kansas Alzheimer's Disease CenterRecruiting
  • Johns Hopkins University School of MedicineRecruiting
  • Mayo Comprehensive Cancer Center - PPDSRecruiting
  • Irving Institute for Clinical and Translational ResearchRecruiting
  • University of North Carolina at Chapel HillRecruiting
  • University Of Cincinnati Gardner Neuroscience instituteRecruiting
  • Case Western Reserve UniversityRecruiting
  • Oregon Health and Science UniversityRecruiting
  • University of PennsylvaniaRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • Houston Methodist Institute for Academic MedicineRecruiting
  • University of Texas Health Science Center at San AntonioRecruiting
  • Froedtert and The Medical College of WisconsinRecruiting
  • CENydET S.R.L.Recruiting
  • Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La InfanciaRecruiting
  • INECO CastañoRecruiting
  • Box Hill HospitalRecruiting
  • Royal Prince Alfred HospitalRecruiting
  • Perron Institute for Neurological and Translational ScienceRecruiting
  • The Queen Elizabeth HospitalRecruiting
  • UZ LeuvenRecruiting
  • The University of Western OntarioRecruiting
  • Sunnybrook Research Institute - University of TorontoRecruiting
  • CHU de Toulouse Hopital PURPANRecruiting
  • Hopital Charles Nicolle - HospitalRecruiting
  • CHU de BordeauxRecruiting
  • CHRU LilleRecruiting
  • Groupe Hospitalier Pitié SalpétrièreRecruiting
  • Uniklinik Köln
  • Klinikum rechts der Isar der Technischen Universität München
  • Universitätsklinikum UlmRecruiting
  • Eginitio University General Hospital of Athens - 1st University Neurology ClinicRecruiting
  • University General Hospital of Alexandroupolis - Department of NeurologyRecruiting
  • Azienda Unita Sanita Locale (ASL) di Reggio Emilia - IRCCSRecruiting
  • Fondazione Istituto G.GiglioRecruiting
  • Nuovo Ospedale Civile S. Agostino-Estense di BaggiovaraRecruiting
  • IRCCS Istituto delle Scienze Neurologiche di BolognaRecruiting
  • ASST degli Spedali Civili di Brescia - Spedali Civili di BresciaRecruiting
  • IRCCS - Centro S. Giovanni di Dio FatebenefratelliRecruiting
  • Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoRecruiting
  • Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo BestaRecruiting
  • Azienda Ospedale Universita Padova
  • PIA Fondazione PanicoRecruiting
  • Erasmus MCRecruiting
  • Centro Hospitalar E Universitário de Coimbra EPERecruiting
  • Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa MariaRecruiting
  • Hospital CUF DescobertasRecruiting
  • Centro Hospitalar do Porto - Hospital de Santo AntónioRecruiting
  • Hospital Universitario Marques de ValdecillaRecruiting
  • Hospital Clinic de BarcelonaRecruiting
  • Hospital Universitario de DonostiaRecruiting
  • Hospital Universitario de La PrincesaRecruiting
  • Hospital Clinico San CarlosRecruiting
  • Karolinska Universitetssjukhuset Huddinge - PPDSRecruiting
  • Felix Platter SpitalRecruiting
  • Dokuz Eylul UniversityRecruiting
  • Istanbul University Medical FacultyRecruiting
  • University College LondonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

AL001

Placebo

Open label - AL001

Arm Description

AL001 every 4 weeks

Placebo every 4 weeks

AL001 every 4 weeks

Outcomes

Primary Outcome Measures

Evaluation of efficacy of AL001 as measured by the CDR® plus NACC FTLD-SB
The Clinical Dementia Rating Dementia Staging Instrument PLUS National Alzheimer's Disease Coordinating Center frontotemporal lobar degeneration Behavior & Language Domains Sum of Boxes (CDR® plus NACC FTLD-SB) is administered by a healthcare professional and based on individual ratings of the eight domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, personal care, language and behavior. Impairment is scored on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2 and severe = 3. The 8 individual domain ratings, or "box scores", were added together to give the CDR® plus NACC FTLD-SB which ranges from 0-24. Higher score indicates severe impairment.

Secondary Outcome Measures

Change in Clinical Global Impression-Severity (CGI-S) Score
The CGI-S is used by a clinician to rate the severity of a participant's disease relative to the clinician's past experience with patients who have the same disease using an ordinal scale ranging from 1=normal, not at all ill; 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=among the most extremely ill patients. Higher scores indicate worsening.
Change in Clinical Global Impression-Improvement (CGI-I) Score
The CGI-I is used by a clinician to rate how much a participant's disease has improved or worsened relative to baseline using an ordinal scale ranging from 1=very much improved; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; and 7=very much worse. Higher scores indicate worsening.
Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score
RBANS is 20 to 25 minute battery developed for cognitive assessment, detection, and characterization of dementia. RBANS includes 12 subtests that measure following 5 indices: (1)Attention Index, composed of Digit Span and Coding; (2)Language Index, consisting of Picture Naming and Semantic Fluency subtests; (3)Visuospatial/Construction Index, made up of Figure Copy and Line Orientation subtests; (4)Immediate Memory Index, composed of List Learning and Story Memory subtests, and (5)Delayed Memory Index, consisting of List Recall, List Recognition, Story Recall, and Figure Recall subtests. Completion of RBANS yields 5 index scores based on participant performance on various subtests, as well as a composite Total Index score for battery. Total index scores range from 40 to 160, and are normalized to a mean of 100 and standard deviation (SD) of 15. Higher scores indicate less impairment.
Pharmacodynamic Biomarkers
Change in magnetic resonance imaging and blood-based biomarkers and optional CSF biomarkers (neurofilament light chain and progranulin)
Evaluation of safety and tolerability of AL001: Incidence of adverse events
Incidence of adverse events

Full Information

First Posted
April 23, 2020
Last Updated
July 28, 2023
Sponsor
Alector Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04374136
Brief Title
A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3)
Official Title
A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 23, 2020 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alector Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A phase 3 double blind, placebo controlled study evaluating the efficacy and safety of AL001 in participants at risk for or with frontotemporal dementia due to heterozygous mutations in the progranulin gene.
Detailed Description
This is a phase 3 double blind, placebo controlled study evaluating the efficacy and safety of AL001 administered intravenously in participants at risk for or with frontotemporal dementia due to heterozygous mutations in the progranulin gene.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frontotemporal Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AL001
Arm Type
Experimental
Arm Description
AL001 every 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo every 4 weeks
Arm Title
Open label - AL001
Arm Type
Experimental
Arm Description
AL001 every 4 weeks
Intervention Type
Drug
Intervention Name(s)
AL001
Intervention Description
Administered via intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered via intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Open label - AL001
Intervention Description
Administered via intravenous (IV) infusion
Primary Outcome Measure Information:
Title
Evaluation of efficacy of AL001 as measured by the CDR® plus NACC FTLD-SB
Description
The Clinical Dementia Rating Dementia Staging Instrument PLUS National Alzheimer's Disease Coordinating Center frontotemporal lobar degeneration Behavior & Language Domains Sum of Boxes (CDR® plus NACC FTLD-SB) is administered by a healthcare professional and based on individual ratings of the eight domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, personal care, language and behavior. Impairment is scored on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2 and severe = 3. The 8 individual domain ratings, or "box scores", were added together to give the CDR® plus NACC FTLD-SB which ranges from 0-24. Higher score indicates severe impairment.
Time Frame
Through study completion, on average up to 96 weeks
Secondary Outcome Measure Information:
Title
Change in Clinical Global Impression-Severity (CGI-S) Score
Description
The CGI-S is used by a clinician to rate the severity of a participant's disease relative to the clinician's past experience with patients who have the same disease using an ordinal scale ranging from 1=normal, not at all ill; 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=among the most extremely ill patients. Higher scores indicate worsening.
Time Frame
Baseline to 96 weeks
Title
Change in Clinical Global Impression-Improvement (CGI-I) Score
Description
The CGI-I is used by a clinician to rate how much a participant's disease has improved or worsened relative to baseline using an ordinal scale ranging from 1=very much improved; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; and 7=very much worse. Higher scores indicate worsening.
Time Frame
Baseline to 96 weeks
Title
Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score
Description
RBANS is 20 to 25 minute battery developed for cognitive assessment, detection, and characterization of dementia. RBANS includes 12 subtests that measure following 5 indices: (1)Attention Index, composed of Digit Span and Coding; (2)Language Index, consisting of Picture Naming and Semantic Fluency subtests; (3)Visuospatial/Construction Index, made up of Figure Copy and Line Orientation subtests; (4)Immediate Memory Index, composed of List Learning and Story Memory subtests, and (5)Delayed Memory Index, consisting of List Recall, List Recognition, Story Recall, and Figure Recall subtests. Completion of RBANS yields 5 index scores based on participant performance on various subtests, as well as a composite Total Index score for battery. Total index scores range from 40 to 160, and are normalized to a mean of 100 and standard deviation (SD) of 15. Higher scores indicate less impairment.
Time Frame
Baseline to 96 weeks
Title
Pharmacodynamic Biomarkers
Description
Change in magnetic resonance imaging and blood-based biomarkers and optional CSF biomarkers (neurofilament light chain and progranulin)
Time Frame
Baseline to 96 weeks
Title
Evaluation of safety and tolerability of AL001: Incidence of adverse events
Description
Incidence of adverse events
Time Frame
Baseline to 96 weeks
Other Pre-specified Outcome Measures:
Title
Optional Open-Label Extension
Description
Assess the long-term safety and tolerability of AL001 in participants who have completed 96 week of treatment
Time Frame
96 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Persons with a progranulin gene mutation and at risk of developing FTD symptoms as evidenced by a biomarker, or persons with a progranulin gene mutation and diagnosed with FTD. If symptomatic, one or more of the criteria for the diagnosis of possible behavioral variant FTD, or a diagnosis of Primary Progressive Aphasia. Study partner who consents to study participation and who cares for/visits the participant daily for at least 5 hours per week. Written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker). Exclusion Criteria: Dementia due to a condition other than FTD including, but not limited to, Alzheimer's disease, Parkinson's disease, dementia with Lewy bodies, Huntington disease, or vascular dementia. Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins. Current uncontrolled hypertension, diabetes mellitus or thyroid disease. Clinically significant heart disease, liver disease or kidney disease. History or evidence of clinically significant brain disease other than FTD. Females who are pregnant or breastfeeding, or planning to conceive within the study period. Any experimental vaccine or gene therapy. History of cancer within the last 5 years. Current use of anticoagulant medications (e.g., coumadin, heparinoids, apixaban). Residence in a skilled nursing facility, convalescent home, or long term care facility at screening; or requires continuous nursing care.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Lead
Phone
650-826-2454
Email
clinicaltrials@alector.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TBD TBD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dignity Health
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0648
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Terminated
Facility Name
University of Miami Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Indiana University Health Neuroscience Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
University of Kansas Alzheimer's Disease Center
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Mayo Comprehensive Cancer Center - PPDS
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Irving Institute for Clinical and Translational Research
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7025
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
University Of Cincinnati Gardner Neuroscience institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordintaor
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Houston Methodist Institute for Academic Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Froedtert and The Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
CENydET S.R.L.
City
Retiro
State/Province
Ciudad Autónoma De BuenosAires
ZIP/Postal Code
C1058AAJ
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coodinator
Facility Name
Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia
City
Buenos Aires
ZIP/Postal Code
2325
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
INECO Castaño
City
San Juan
ZIP/Postal Code
C1015ABR
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coodinator
Facility Name
Box Hill Hospital
City
Box Hill
ZIP/Postal Code
3128
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Corodinator
Facility Name
Perron Institute for Neurological and Translational Science
City
Subiaco
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
The Queen Elizabeth Hospital
City
Woodville
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
The University of Western Ontario
City
London
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Sunnybrook Research Institute - University of Toronto
City
Toronto
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
CHU de Toulouse Hopital PURPAN
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Hopital Charles Nicolle - Hospital
City
Rouen
State/Province
Seinne-Maritime
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
CHU de Bordeaux
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
CHRU Lille
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Groupe Hospitalier Pitié Salpétrière
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Uniklinik Köln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Klinikum rechts der Isar der Technischen Universität München
City
München
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Universitätsklinikum Ulm
City
Ulm
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Eginitio University General Hospital of Athens - 1st University Neurology Clinic
City
Athens
State/Province
Attica
ZIP/Postal Code
115 28
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coodinator
Facility Name
University General Hospital of Alexandroupolis - Department of Neurology
City
Alexandroupoli
State/Province
Evros
ZIP/Postal Code
68100
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coodinator
Facility Name
Azienda Unita Sanita Locale (ASL) di Reggio Emilia - IRCCS
City
Reggio Emilia
State/Province
Emilia Romagna
ZIP/Postal Code
42122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Fondazione Istituto G.Giglio
City
Cefalù
State/Province
Palermo
ZIP/Postal Code
90015
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Nuovo Ospedale Civile S. Agostino-Estense di Baggiovara
City
Baggiovara
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
IRCCS Istituto delle Scienze Neurologiche di Bologna
City
Bologna
ZIP/Postal Code
40139
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
City
Brescia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
IRCCS - Centro S. Giovanni di Dio Fatebenefratelli
City
Brescia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Azienda Ospedale Universita Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
PIA Fondazione Panico
City
Tricase
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Cooridnator
Facility Name
Erasmus MC
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Centro Hospitalar E Universitário de Coimbra EPE
City
Coimbra
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordintaor
Facility Name
Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Hospital CUF Descobertas
City
Lisboa
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Centro Hospitalar do Porto - Hospital de Santo António
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Hospital Universitario de Donostia
City
Donostia-san Sebastián
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Karolinska Universitetssjukhuset Huddinge - PPDS
City
Huddinge
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Felix Platter Spital
City
Basel
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Dokuz Eylul University
City
Izmir
State/Province
Balcova
ZIP/Postal Code
35330
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Istanbul University Medical Faculty
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
University College London
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator

12. IPD Sharing Statement

Learn more about this trial

A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3)

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