Your session is about to expire
← Back to Search
AL001 for Frontotemporal Dementia
Phase 3
Waitlist Available
Led By TBD TBD
Research Sponsored by Alector Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 96 weeks
Awards & highlights
Study Summary
This trial is testing a new drug, AL001, to see if it is effective and safe for people with frontotemporal dementia who have a certain mutation.
Who is the study for?
This trial is for people with a specific gene mutation linked to frontotemporal dementia (FTD), including those at risk of developing FTD or diagnosed with it. Participants need a study partner available for support, and they must not be pregnant, planning pregnancy, or have significant heart, liver, kidney diseases, uncontrolled diabetes or hypertension.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of AL001 in treating FTD compared to a placebo. Some participants will receive AL001 openly. It's designed as a phase 3 double-blind study where neither the researchers nor participants know who gets the real treatment versus placebo.See study design
What are the potential side effects?
While specific side effects are not listed here, similar treatments often cause reactions at injection sites, allergic responses to components of the drug (like chimeric antibodies), and may affect organ function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a progranulin gene mutation and am at risk of or have been diagnosed with FTD.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 96 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~96 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluation of efficacy of AL001 as measured by the CDR® plus NACC FTLD-SB
Secondary outcome measures
Change in Clinical Global Impression-Improvement (CGI-I) Score
Change in Clinical Global Impression-Severity (CGI-S) Score
Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score
+2 moreOther outcome measures
Optional Open-Label Extension
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Open label - AL001Experimental Treatment1 Intervention
AL001 every 4 weeks
Group II: AL001Experimental Treatment1 Intervention
AL001 every 4 weeks
Group III: PlaceboPlacebo Group1 Intervention
Placebo every 4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AL001
2018
Completed Phase 1
~70
Find a Location
Who is running the clinical trial?
Alector Inc.Lead Sponsor
10 Previous Clinical Trials
1,175 Total Patients Enrolled
2 Trials studying Frontotemporal Dementia
104 Patients Enrolled for Frontotemporal Dementia
TBD TBDPrincipal Investigator
6 Previous Clinical Trials
1,514 Total Patients Enrolled
Peter Ljubenkov, MDPrincipal InvestigatorUniversity of California, San Francisco
3 Previous Clinical Trials
119 Total Patients Enrolled
2 Trials studying Frontotemporal Dementia
104 Patients Enrolled for Frontotemporal Dementia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had severe allergic reactions to certain types of medications made from human or animal proteins.I have had cancer in the past 5 years.I have a progranulin gene mutation and am at risk of or have been diagnosed with FTD.I do not have uncontrolled high blood pressure, diabetes, thyroid, heart, liver, or kidney disease, and no significant brain disease other than FTD.I am not pregnant, breastfeeding, nor planning to conceive during the study.I have symptoms of FTD or have been diagnosed with Primary Progressive Aphasia.I have not received any experimental vaccines or gene therapy.I live in a care facility or need constant nursing care.I am currently taking blood thinners.My dementia is not caused by frontotemporal dementia (FTD) but another condition.
Research Study Groups:
This trial has the following groups:- Group 1: Open label - AL001
- Group 2: Placebo
- Group 3: AL001
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frontotemporal Dementia Patient Testimony for trial: Trial Name: NCT04374136 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the success rate of AL001 in human trials?
"There is existing clinical data that suggests AL001 is safe for use, as it has gone through multiple rounds of testing. Consequently, our team at Power gave it a score of 3."
Answered by AI
Are volunteers currently being enrolled in this research study?
"This trial, which is currently looking for patients, was first posted on clinicaltrials.gov on 7/23/2020 and was last edited on 9/14/2022."
Answered by AI
Does this research study include participants who are under 25 years old?
"This specific clinical trial is only open to patients between the ages of 25 and 85. There are 32 other trials that cater to patients below 18 years old and 426 for senior citizens above 65."
Answered by AI
Am I able to sign-up for this clinical study?
"This study is seeking 180 individuals aged 25 to 85 that have semantic dementia. The following are also required of potential patients: a study partner who agrees to participate and visit the patient for at least 5 hours per week, if symptomatic, one or more criteria for the diagnosis of possible behavioral variant FTD, or a diagnosis of Primary progressive aphasia."
Answered by AI
Who else is applying?
What state do they live in?
Colorado
Florida
How old are they?
18 - 65
What site did they apply to?
University of California San Diego
University of Colorado
University of Miami Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
What questions have other patients asked about this trial?
How often will we need to go to the clinic? Will he be required to discontinue his Namenda? How can we ensure he is NOT in the placebo arm of this trial?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
This it's new for me and I'm scare, and need more information.
PatientReceived 1 prior treatment
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger