Your session is about to expire
← Back to Search
RNAi Therapeutics
ALN-APP for Alzheimer's Disease
Phase 1
Recruiting
Research Sponsored by Alnylam Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has mild cognitive impairment or mild dementia due to EOAD
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part a up to 14 months; part b up to 24 months
Awards & highlights
Study Summary
This trial is to study the safety of a single dose of ALN-APP, a new drug for Alzheimer's, in adults. Part A is a single dose, and Part B is 12 months.
Who is the study for?
This trial is for adults with early-onset Alzheimer's Disease (EOAD) who have mild cognitive impairment or dementia. Participants should have a CDR score of 0.5 or 1.0 and an MMSE score over 20, indicating some memory issues but not severe dementia. People can't join if they have poor kidney function, recently took experimental drugs, suffer from non-Alzheimer's dementias, or have certain liver enzyme levels that are too high.Check my eligibility
What is being tested?
The study tests the safety and effects of ALN-APP given through spinal injection to EOAD patients compared to a placebo group receiving no active treatment. The drug's behavior in the body (pharmacokinetics) and its impact on disease processes (pharmacodynamics) will be monitored for up to one year.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones may include discomfort at the injection site, potential allergic reactions to components of ALN-APP, headache, nausea, back pain and possible changes in cognition or mood.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have mild memory problems or mild dementia from early-onset Alzheimer's.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ part a up to 14 months; part b up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part a up to 14 months; part b up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part A: Frequency of Adverse Events
Part B: Frequency of Adverse Events
Secondary outcome measures
Part A and Part B: Area Under the Plasma Concentration-time Curve (AUC) of ALN-APP and of Potential Metabolites
Part A and Part B: Change from Baseline in Levels of Cerebrospinal Fluid (CSF) Soluble Amyloid Precursor Protein Alpha (sAPPα) and Soluble Amyloid Precursor Protein Beta (sAPPβ)
Part A and Part B: Concentration at Time 't' (Ct) of ALN-APP and Potential Metabolites
+2 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B:Experimental Treatment1 Intervention
Participants will be administered multiple doses of ALN-APP.
Group II: Part A: ALN-APPExperimental Treatment1 Intervention
Participants will be administered a single dose of ALN-APP.
Group III: Part A: PlaceboPlacebo Group1 Intervention
Participants will be administered a single dose of placebo.
Find a Location
Who is running the clinical trial?
Alnylam PharmaceuticalsLead Sponsor
72 Previous Clinical Trials
14,758 Total Patients Enrolled
Medical DirectorStudy DirectorAlnylam Pharmaceuticals
2,777 Previous Clinical Trials
8,063,804 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have mild memory problems or mild dementia from early-onset Alzheimer's.Your ALT or AST levels are more than twice the normal limit.My kidney function is reduced, with an eGFR below 45.My condition is dementia, but not Alzheimer's disease.You have mild cognitive impairment with a specific score on two different memory tests.You have taken a new, experimental medication recently.I recently received treatment with an amyloid-targeting antibody.
Research Study Groups:
This trial has the following groups:- Group 1: Part B:
- Group 2: Part A: Placebo
- Group 3: Part A: ALN-APP
Awards:
This trial has 0 awards, including: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.
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT05231785 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there any availability for participants in this trial?
"Yes, according to clinicaltrials.gov this trial is actively recruiting participants. Initially published on February 4th 2022 and last modified November 7th of the same year. This study requires 60 individuals from two distinct sites to take part in it."
Answered by AI
Has ALN-APP acquired governmental authorization for usage?
"As this is a Phase 1 trial and there are few studies that validate ALN-APP's safety or efficacy, our team has assigned it a score of 1 on the risk scale."
Answered by AI
What is the participant capacity of this research endeavor?
"Yes, clinicaltrials.gov indicates that this medical trial is actively recruiting volunteers at two sites with a total of 60 participants sought after. The study originated on February 4th 2022 and was recently updated on November 7th 2022."
Answered by AI
Who else is applying?
What state do they live in?
California
Ohio
What site did they apply to?
Clinical Trial Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
What questions have other patients asked about this trial?
Are there any side effects? How is this coordinated with the medical team I am currently working with?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
Just read about ALN-APP clinical trial, phase one, in Amsterdam. Sounds very promising.
PatientReceived 2+ prior treatments
My husband has just been diagnosed with early onset Alzheimer’s, he is just 56 and we are keen to try any trial, so we can prolong his lucidity as long as possible. We have heard that this drug is ground breaking and we would like to see its results. Our postcode is SA33 4UJ, it wouldn’t allow me to put it in the zip code field. Thank you.
PatientReceived no prior treatments
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger