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Virus Therapy
AAV2-BDNF Gene Therapy for Alzheimer's Disease
Phase 1
Recruiting
Led By Mark Tuszynski, M.D., Ph.D.
Research Sponsored by Mark Tuszynski
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Minimum age 50
Diagnosis of dementia due to Alzheimer's Disease (AD) by National Institute of Aging (NIA) - Alzheimer's Association (AA) criteria for AD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial will test whether a protein can slow or prevent cell loss in the brains of people affected by Alzheimer's disease and Mild Cognitive Impairment.
Who is the study for?
This trial is for people aged 50-80 in San Diego, Orange Counties, California or Ohio with early Alzheimer's or Mild Cognitive Impairment. They must speak English without communication issues and have a caregiver. Participants need to be generally healthy, not pregnant, and have stable medication use for at least one month.Check my eligibility
What is being tested?
The trial tests AAV2-BDNF Gene Therapy as a potential treatment for Alzheimer's Disease and Mild Cognitive Impairment. It involves using a harmless virus to deliver BDNF protein into the brain to protect against cell loss and activate remaining cells.See study design
What are the potential side effects?
As this is a first-in-human trial of gene therapy, specific side effects are unknown but may include reactions related to the immune system's response to the viral vector or new protein production.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 years old or older.
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I have been diagnosed with Alzheimer's Disease according to NIA-AA criteria.
Select...
My recent brain scans show no signs of disease.
Select...
I can see and hear well enough for brain function tests.
Select...
I am between 50 and 80 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Memory change tested on Benson Complex Figure Draw and Memory
Memory change tested on Ray Auditory Verbal Learning Task
Safety as assessed by mumber of participants with treatment-related adverse events assessed on MRI scan
Secondary outcome measures
Change in Biomarkers including CSF amyloid, tau and neurofilament
Efficacy on PET scan reflected by change in fluorodeoxyglucose (FDG) PET scan
Memory change tested on mini-mental status examination (MMSE)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Gene transfer of AAV2-BDNFExperimental Treatment1 Intervention
Up to 12 subjects will receive open-label AAV2-BDNF
Find a Location
Who is running the clinical trial?
Case Western Reserve UniversityOTHER
299 Previous Clinical Trials
246,570 Total Patients Enrolled
Mark TuszynskiLead Sponsor
Ohio State UniversityOTHER
830 Previous Clinical Trials
505,608 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not been diagnosed with major depression or a significant psychiatric disorder in the last two years.I am 50 years old or older.I have been diagnosed with Alzheimer's Disease according to NIA-AA criteria.I have a history of cancer.My recent brain scans show no signs of disease.I do not have any major neurological conditions.Your score on a mental exam is between 24 and 29.I can see and hear well enough for brain function tests.Your brain wave test (EEG) does not show signs of epilepsy.I have had a condition where my lymphocytes grow abnormally.Your heart test (ECG) does not show any major problems.I haven't had cancer in the last 5 years, except for skin cancer.I have not experienced severe mental health issues like psychosis or extreme agitation in the last three months.I have had cancer elsewhere in my body within the last 18 months.I am not taking any medications that are not allowed in the study.You have had problems with drinking too much alcohol or using drugs in the past two years.You have been diagnosed with schizophrenia in the past.I have had thoughts of suicide in the last 3 months.I do not have any severe illnesses or unstable health conditions.You do not have a serious brain blood vessel disease, as indicated by a modified Hachinski score of 4 or lower.My medications have been the same for at least one month.I am in good health with no other illnesses that could affect the study.Your blood tests for B12, RPR, and thyroid function are normal, or any minor issues won't affect your participation.You have been diagnosed with mild cognitive impairment.I am between 50 and 80 years old.I was diagnosed with Alzheimer's within 3 years of noticing memory loss.
Research Study Groups:
This trial has the following groups:- Group 1: Gene transfer of AAV2-BDNF
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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: NCT05040217 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are elderly individuals aged 55 and above qualified to participate in this experiment?
"This research project is recruiting participants aged from 50 years old to 80 years of age."
Answered by AI
What is the desired outcome of this medical experiment?
"This clinical trial, which will be observed over a two year period, is primarily designed to evaluate the safety of participants using Magnetic Resonance Imaging (MRI). The secondary outcome measures include Memory change tested on mini-mental status examination (MMSE), Memory evaluated by Alzheimer's disease Assessment Scale - Cognitive component (ADAS-Cog) and Efficacy indicated through Positron Emission Tomography scans reflected by changes in fluorodeoxyglucose levels."
Answered by AI
May I apply to join this experiment?
"Qualified participants for this trial will be diagnosed with Alzheimer's disease, aged between 50 and 80 years old. A maximum of 12 people can join the experiment."
Answered by AI
Are there any vacancies available for enrolment in the trial?
"According to the clinicaltrials.gov website, this specific medical trial is not seeking participants at present. Initially posted on October 15th 2022 and last updated five days later, there are still 980 other trials that require patient recruitment."
Answered by AI
To what extent is AAV2-BDNF Gene Therapy a viable treatment option?
"With limited data to support safety and efficacy, AAV2-BDNF Gene Therapy receives a score of 1 on the risk assessment scale."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
Illinois
Texas
How old are they?
18 - 65
What site did they apply to?
Case Western Reserve University
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I function normally now and only forget some details. I did a study a year ago and function well with some mental decline but nothing alarming. I hope to join another study to reduce the possibility of dementia. Happy that at 71 I and very functional. But I definitely have dementia.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
When do the screening test happen? If I get accepted, where would I go?
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
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