Frontotemporal DementiaPhase 3NCT04374136
A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3)
A Phase 3 study testing Part 1 Blinded - AL001 and Part 2 (OLE Treatment) - AL001 in people with Frontotemporal Dementia, run by Alector Inc. at 44 sites in 16 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Frontotemporal Dementia
- What is being tested?
- Part 1 Blinded - AL001 and Part 2 (OLE Treatment) - AL001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 44 sitesin 16 countries
- Study dates
- 23 Jul 2020to 6 Jan 2026
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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, unless in remission or stable/adequately controlled.
- 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.
Trial locations and contacts
44 sites in 16 countries.
44 sites in 16 countries
United States14 sites
Emory University
Atlanta, Georgia, 30329
University of Colorado
Aurora, Colorado, 80045
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
University Of Cincinnati Gardner Neuroscience institute
Cincinnati, Ohio, 45219
University of Kansas Alzheimer's Disease Center
Fairway, Kansas, 66205
Houston Methodist Institute for Academic Medicine
Houston, Texas, 77030
Indiana University Health Neuroscience Center
Indianapolis, Indiana, 46202
University of California San Diego
La Jolla, California, 92093
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Irving Institute for Clinical and Translational Research
New York, New York, 10032
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Dignity Health
Phoenix, Arizona, 85013
Oregon Health and Science University
Portland, Oregon, 97239
Mayo Comprehensive Cancer Center - PPDS
Rochester, Minnesota, 55905
Italy6 sites
Nuovo Ospedale Civile S. Agostino-Estense di Baggiovara
Baggiovara, 41126
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Brescia, 25125
IRCCS - Centro S. Giovanni di Dio Fatebenefratelli
Brescia, 25125
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, 20122
Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta
Milan, 20133
PIA Fondazione Panico
Tricase, 73039
Portugal4 sites
Centro Hospitalar E Universitário de Coimbra EPE
Coimbra, 3000-075
Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria
Lisbon, 1649-035
Hospital CUF Descobertas
Lisbon, 1998-018
Centro Hospitalar do Porto - Hospital de Santo António
Porto, Porto District, 4099-001
France3 sites
CHU de Bordeaux
Bordeaux, 33404
CHRU Lille
Lille, 59000
Groupe Hospitalier Pitié Salpétrière
Paris, 75651
Australia2 sites
Box Hill Hospital
Box Hill, 3128
The Queen Elizabeth Hospital
Woodville, 5011
Canada2 sites
The University of Western Ontario
London, N6A 3K7
Sunnybrook Research Institute - University of Toronto
Toronto, M4N 3M5
Germany2 sites
Uniklinik Köln
Cologne, 50937
Universitätsklinikum Ulm
Ulm, 89075
Greece2 sites
University General Hospital of Alexandroupolis - Department of Neurology
Alexandroupoli, Evros, 68100
Eginitio University General Hospital of Athens - 1st University Neurology Clinic
Athens, Attica, 115 28
Spain2 sites
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Universitario de Donostia
Donostia / San Sebastian, 20014
Argentina1 site
Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia
Buenos Aires, C1428AQK
Turkey (Türkiye)1 site
Istanbul University Medical Faculty
Istanbul, Fatih, 34093
About this study
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
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.
Read the 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. Study completion marks the end of the open label extension period following the 96-week blinded portion of the study.
- Conditions
- Frontotemporal Dementia
- Being tested
- Part 1 Blinded - AL001, Part 1 Blinded - Placebo, Part 2 (OLE Treatment) - AL001, Part 2 (OLE Treatment) - Placebo Switched to AL001
- Medical subject headings
- Frontotemporal Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part 1 Blinded - AL001Drug
Administered via intravenous (IV) infusion
Part 1 Blinded - PlaceboDrug
Administered via intravenous (IV) infusion
Part 2 (OLE Treatment) - AL001Drug
Administered via intravenous (IV) infusion
Part 2 (OLE Treatment) - Placebo Switched to AL001Drug
Administered via intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Blinded - AL001 | Experimental | Participants receive AL001 60 mg/kg administered by intravenous (IV) infusion every 4 weeks during the double-blind treatment period. Receives: Drug: Part 1 Blinded - AL001 |
| Part 1 Blinded - Placebo | Placebo comparator | Participants receive placebo administered by intravenous (IV) infusion every 4 weeks during the double-blind treatment period. Receives: Drug: Part 1 Blinded - Placebo |
| Part 2 (OLE Treatment) - AL001 | Experimental | Participants who received AL001 during the double-blind treatment period and enroll in the optional open-label extension receive AL001 60 mg/kg administered by intravenous (IV) infusion every 4 weeks. Receives: Drug: Part 2 (OLE Treatment) - AL001 |
| Part 2 (OLE Treatment) - Placebo Switched to AL001 | Experimental | Participants who received placebo during the double-blind treatment period and enroll in the optional open-label extension receive AL001 60 mg/kg administered by intravenous (IV) infusion every 4 weeks. Receives: Drug: Part 2 (OLE Treatment) - Placebo Switched to AL001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 Double Blind - Evaluation of Efficacy of AL001 Compared With Placebo as Measured by the CDR® Plus NACC FTLD-SB in Symptomatic Patients
Part 1 Primary Endpoint - Change from baseline to Weeks 48, 72, and 96 in 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.
Measured: Through study completion, on average up to 96 weeks
Part 1 Double Blind (Co-Primary US Endpoint) - Evaluation of the Treatment Effect of AL001 Compared With Placebo as Measured by Pharmacodynamic and Disease Pathology Biomarkers in Symptomatic Patients
Geometric Mean Fold Change from baseline to Week 96 in PGRN concentrations in plasma
Measured: Baseline to 96 weeks
Part 2 OLE - To Assess the Long-term Safety and Tolerability of AL001 in Participants Who Have Completed Part 1 of the Study
Part 2 OLE Primary Endpoint - Incidence, nature, and severity of AEs and SAEs in Part 2 OLE
Measured: 96 weeks
Secondary outcomes (5)
Part 1 Double Blind - Evaluation of Efficacy of AL001 Compared With Placebo in Symptomatic Participants as Measured by CGI-S
Change from baseline to Weeks 48, 72, and 96 on the CGI-S. 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.
Measured: Baseline to 96 weeks
Part 1 Double Blind - Evaluation of Efficacy of AL001 Compared With Placebo in Symptomatic Participants as Measured by CGI-I
Actual values at Weeks 48, 72, and 96 on the CGI-I. 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.
Measured: Baseline to 96 weeks
Part 1 Double Blind - Evaluation of Efficacy of AL001 Compared With Placebo in Symptomatic Participants as Measured by Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score
Change from baseline to Weeks 48, 72, and 96 on the RBANS. 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.
Measured: Baseline to 96 weeks
Part 1 Double Blind - Evaluation of the Safety and Tolerability of AL001 Compared With Placebo as Measured by Safety Assessments
Incidence of adverse events
Measured: Baseline to 96 weeks
Part 1 Double Blind: Clinical Progression as Measured by Frontotemporal Dementia Rating Scale (FRS) Logit Score in Symptomatic Participants
The FRS is a 30-item scale with item responses of 'All the time,' 'Sometimes,' 'Never,' or 'Not applicable' for each item. The total percentage score is calculated as the number of items with a response of 'Never,' divided by the number of applicable items, excluding those marked 'not applicable.' The percentage score ranges from 0 to 100, inclusive, with higher scores indicating better function (fewer behavioral/functional problems) and lower scores indicating worse function. The percentage score is converted to a logit score ranging from -6.66 to 5.39 using a look-up table defined as part of the FRS instrument, where a higher (more positive) logit score indicates better function/less disease severity (5.39 = normal) and a lower (more negative) logit score indicates worse function/greater disease severity (-6.66 = advanced/profound impairment). A decrease in logit score over time reflects clinical progression
Measured: baseline to 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start23 Jul 2020
- Primary completion1 Sep 2025
- Study completion6 Jan 2026
Why it stopped: The trial did not meet the clinical co-primary endpoint of slowing FTD-GRN progression, as measured by the Clinical Dementia Rating® plus National Alzheimer's Coordinating Center Frontotemporal Lobar Degeneration Sum of Boxes (CDR® plus NACC FTLD-SB)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Frontotemporal DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alector Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374136
- Sponsor's protocol ID
- AL001-3
- Status last verified
- Aug 2026
- First submitted
- 23 Apr 2020
- Last updated
- 21 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04374136
- Acronym / sponsor ID
- AL001-3
- Conditions
- Frontotemporal Dementia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial did not meet the clinical co-primary endpoint of slowing FTD-GRN progression, as measured by the Clinical Dementia Rating® plus National Alzheimer's Coordinating Center Frontotemporal Lobar Degeneration Sum of Boxes (CDR® plus NACC FTLD-SB)
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Alector Inc.Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 6 Jan 2026 (actual)
- First posted
- 5 May 2020 (actual)
- Results
- Posted 21 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Study completion marks the end of the open label extension period following the 96-week blinded portion of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1 Blinded - AL001 | Experimental | Drug: Part 1 Blinded - AL001Participants receive AL001 60 mg/kg administered by intravenous (IV) infusion every 4 weeks during the double-blind treatment period. |
| Part 1 Blinded - Placebo | Placebo comparator | Drug: Part 1 Blinded - PlaceboParticipants receive placebo administered by intravenous (IV) infusion every 4 weeks during the double-blind treatment period. |
| Part 2 (OLE Treatment) - AL001 | Experimental | Drug: Part 2 (OLE Treatment) - AL001Participants who received AL001 during the double-blind treatment period and enroll in the optional open-label extension receive AL001 60 mg/kg administered by intravenous (IV) infusion every 4 weeks. |
| Part 2 (OLE Treatment) - Placebo Switched to AL001 | Experimental | Drug: Part 2 (OLE Treatment) - Placebo Switched to AL001Participants who received placebo during the double-blind treatment period and enroll in the optional open-label extension receive AL001 60 mg/kg administered by intravenous (IV) infusion every 4 weeks. |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Part 1 Blinded - AL001Administered via intravenous (IV) infusion | Drug | Part 1 Blinded - AL001 |
| Part 1 Blinded - PlaceboAdministered via intravenous (IV) infusion | Drug | Part 1 Blinded - Placebo |
| Part 2 (OLE Treatment) - AL001Administered via intravenous (IV) infusion | Drug | Part 2 (OLE Treatment) - AL001 |
| Part 2 (OLE Treatment) - Placebo Switched to AL001Administered via intravenous (IV) infusion | Drug | Part 2 (OLE Treatment) - Placebo Switched to AL001 |
Primary outcome
Part 1 Double Blind - Evaluation of Efficacy of AL001 Compared With Placebo as Measured by the CDR® Plus NACC FTLD-SB in Symptomatic Patients
Time frame: Through study completion, on average up to 96 weeks
Part 1 Primary Endpoint - Change from baseline to Weeks 48, 72, and 96 in 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.
Part 1 Double Blind (Co-Primary US Endpoint) - Evaluation of the Treatment Effect of AL001 Compared With Placebo as Measured by Pharmacodynamic and Disease Pathology Biomarkers in Symptomatic Patients
Time frame: Baseline to 96 weeks
Geometric Mean Fold Change from baseline to Week 96 in PGRN concentrations in plasma
Part 2 OLE - To Assess the Long-term Safety and Tolerability of AL001 in Participants Who Have Completed Part 1 of the Study
Time frame: 96 weeks
Part 2 OLE Primary Endpoint - Incidence, nature, and severity of AEs and SAEs in Part 2 OLE
5 secondary outcomes
Part 1 Double Blind - Evaluation of Efficacy of AL001 Compared With Placebo in Symptomatic Participants as Measured by CGI-S
Time frame: Baseline to 96 weeks
Part 1 Double Blind - Evaluation of Efficacy of AL001 Compared With Placebo in Symptomatic Participants as Measured by CGI-I
Time frame: Baseline to 96 weeks
Part 1 Double Blind - Evaluation of Efficacy of AL001 Compared With Placebo in Symptomatic Participants as Measured by Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score
Time frame: Baseline to 96 weeks
Part 1 Double Blind - Evaluation of the Safety and Tolerability of AL001 Compared With Placebo as Measured by Safety Assessments
Time frame: Baseline to 96 weeks
Part 1 Double Blind: Clinical Progression as Measured by Frontotemporal Dementia Rating Scale (FRS) Logit Score in Symptomatic Participants
Time frame: baseline to 96 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
44 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Part 1 Blinded - AL001 and Part 2 (OLE Treatment) - AL001 in people with Frontotemporal Dementia, run by Alector Inc. at 44 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Italy, Portugal, France, Australia and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 Double Blind - Evaluation of Efficacy of AL001 Compared With Placebo as Measured by the CDR® Plus NACC FTLD-SB in Symptomatic Patients (time frame: Through study completion, on average up to 96 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.