Neurodegenerative DiseasesPhase 3NCT06111014
Continuation Study for Latozinemab
A Phase 3 study testing Latozinemab in people with Neurodegenerative Diseases, run by Alector Inc. at 18 sites in 10 countries.
Trial summary
Continuation study to provide continued access to latozinemab for participants who have previously participated in a latozinemab study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurodegenerative Diseases
- What is being tested?
- Latozinemab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 18 sitesin 10 countries
- Study dates
- 8 Dec 2023to 7 Jan 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker).
- Has successfully completed participation in their parent latozinemab study.
- Female participants must be nonpregnant and nonlactating.
- Male participants must agree to acceptable contraception use.
Who cannot join
- Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
- Clinically significant heart disease, liver disease or kidney disease. History or evidence of clinically significant brain disease other than FTD.
Trial locations and contacts
18 sites in 10 countries.
18 sites in 10 countries
United States5 sites
University of Cincinnati Gardner Neuroscience Institute
Cincinnati, Ohio, 45219
Irving Institute for Clinical and Translational Research
New York, New York, 10032
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Dignity Health - Arizona
Phoenix, Arizona, 85013
Mayo Comprehensive Cancer Center - PPDS
Rochester, Minnesota, 55905
Italy3 sites
IRCCS - Centro S. Giovanni di Dio Fatebenefratelli
Brescia, 25125
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico -Via Fracesco Sforza 35
Milan, 20122
Azienda Ospedaliero Universitaria Di Modena Policlinico
Modena, 41126
Canada2 sites
Parkwood Institute
London, Ontario, N6C 0A7
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Portugal2 sites
Centro Hospitalar E Universitario de Coimbra EPE
Coimbra, 3000-075
Centro Hospitalar Universitário Lisboa Norte, EPE - Hospital de Santa Maria
Lisbon, 1649-028
About this study
Official title: A Continuation Study of Latozinemab in Participants With Neurodegenerative Disease
Continuation study to provide continued access to latozinemab for participants who have previously participated in a latozinemab study
Read the detailed description
This is an open-label continuation study to provide access and assess the safety and tolerability of latozinemab in participants who have completed participation in their parent latozinemab study.
All participants will receive open-label latozinemab at a dose of 60/mg/kg, every 4 weeks (q4w).
- Conditions
- Neurodegenerative Diseases
- Being tested
- Latozinemab
- Keywords
- Frontotemporal Dementia (FTD), Amyotrophic Lateral Sclerosis (ALS)
- Medical subject headings
- Neurodegenerative Diseases, Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LatozinemabDrug
Also called AL001
All participants will receive open-label latozinemab at a dose of 60/mg/kg, every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Experimental | Latozinemab (AL001) administered by IV infusion over 60 minutes, q4w Receives: Drug: Latozinemab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants receiving latozinemab
Number of participants receiving latozinemab
Measured: Through study completion, up to 190 weeks
Duration of treatment with latozinemab
Duration of treatment with latozinemab
Measured: Through study completion, up to 190 weeks
Secondary outcomes (3)
Incident of adverse events (AEs) and serious adverse events (SAEs)
Number and percentage of participants of AEs or SAEs
Measured: Through study completion, up to 190 weeks
Nature and severity of AEs and SAEs
Severity of AEs and SAEs according to the World Health Organization (WHO) toxicity grading scale
Measured: Through study completion, up to 190 weeks
Incidence of ADAs to latozinemab
Number and percentage of participants with anti-Drug Antibodies (ADA) titer over study time points
Measured: Through study completion, up to 190 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start8 Dec 2023
- Primary completion1 Sep 2025
- Study completion7 Jan 2026
Why it stopped: The AL001-CS-302 study was terminated because its Phase 3 placebo-controlled parent study (AL001-3) failed to meet the clinical co-primary endpoint of slowing FTD-GRN progression, as measured by the Clinical Dementia Rating® plus National Alzheimer's
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodegenerative DiseasesStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alector Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Lead, Study director, Alector Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111014
- Sponsor's protocol ID
- AL001-CS-302
- Other IDs
- 2023-506805-20-00, 2023
- Status last verified
- Jan 2026
- First submitted
- 18 Oct 2023
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Continuation Study of Latozinemab in Participants With Neurodegenerative Disease
- ClinicalTrials.gov ID
- NCT06111014
- Acronym / sponsor ID
- AL001-CS-302
- Conditions
- Neurodegenerative Diseases
- Keywords
- Frontotemporal Dementia (FTD), Amyotrophic Lateral Sclerosis (ALS)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The AL001-CS-302 study was terminated because its Phase 3 placebo-controlled parent study (AL001-3) failed to meet the clinical co-primary endpoint of slowing FTD-GRN progression, as measured by the Clinical Dementia Rating® plus National Alzheimer's
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Alector Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 7 Jan 2026 (actual)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Continuation study to provide continued access to latozinemab for participants who have previously participated in a latozinemab study
Detailed description
This is an open-label continuation study to provide access and assess the safety and tolerability of latozinemab in participants who have completed participation in their parent latozinemab study.
All participants will receive open-label latozinemab at a dose of 60/mg/kg, every 4 weeks (q4w).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label
| Arm | Type | Receives |
|---|---|---|
| Open Label | Experimental | Drug: LatozinemabLatozinemab (AL001) administered by IV infusion over 60 minutes, q4w |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker).
- Has successfully completed participation in their parent latozinemab study.
- Female participants must be nonpregnant and nonlactating.
- Male participants must agree to acceptable contraception use.
Key exclusion criteria (2 listed)
- Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
- Clinically significant heart disease, liver disease or kidney disease. History or evidence of clinically significant brain disease other than FTD.
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 |
|---|---|---|
| LatozinemabAlso: AL001All participants will receive open-label latozinemab at a dose of 60/mg/kg, every 4 weeks | Drug | Open Label |
Primary outcome
Number of participants receiving latozinemab
Time frame: Through study completion, up to 190 weeks
Number of participants receiving latozinemab
Duration of treatment with latozinemab
Time frame: Through study completion, up to 190 weeks
Duration of treatment with latozinemab
3 secondary outcomes
Incident of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Through study completion, up to 190 weeks
Nature and severity of AEs and SAEs
Time frame: Through study completion, up to 190 weeks
Incidence of ADAs to latozinemab
Time frame: Through study completion, up to 190 weeks
Results and safety
The study was stopped early (reason given: The AL001-CS-302 study was terminated because its Phase 3 placebo-controlled parent study (AL001-3) failed to meet the clinical co-primary endpoint of slowing FTD-GRN progression, as measured by the Clinical Dementia Rating® plus National Alzheimer's). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Study Lead study director
Alector Inc.
18 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Latozinemab in people with Neurodegenerative Diseases, run by Alector Inc. at 18 sites in 10 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 2 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 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Italy, Canada, Portugal, Belgium and 5 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. 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?
The study was stopped early (reason given: The AL001-CS-302 study was terminated because its Phase 3 placebo-controlled parent study (AL001-3) failed to meet the clinical co-primary endpoint of slowing FTD-GRN progression, as measured by the Clinical Dementia Rating® plus National Alzheimer's). Results are not available in the source record.
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?
Number of participants receiving latozinemab (time frame: Through study completion, up to 190 weeks). The study lists 2 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 Jan 2026; AzTrials last refreshed its copy on 28 Oct 2026.