Ignite Creation Date:
2024-05-06 @ 2:23 AM
Last Modification Date:
2024-10-26 @ 11:17 AM
Study NCT ID:
NCT02031198
Status:
COMPLETED
Last Update Posted:
2017-03-17
First Post:
2014-01-07
Brief Title:
18-months Safety Follow-up Study of AADvac1 an Active Tau Vaccine for Alzheimers Disease
Sponsor:
Axon Neuroscience SE
Organization:
Axon Neuroscience SE
Study Overview
Official Title:
An 18-months Open Label Phase I Follow-up Study on Patients With Alzheimers Disease Who Have Completed the AADvac1 Phase I Study AXON CO 18700
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FUNDAMANT
Brief Summary:
This follow-up study continues to observe patients who have completed the phase 1 trial of AADvac1 for another 18 months
Long-term safety and behavior of the immune response to AADvac1 over time are the main points of interest
AADvac1 is a vaccine directed against pathologically modified Alzheimer tau protein that is the main constituent of neurofibrillary tangles NFTs and is intended to be a disease-modifying treatment for Alzheimers disease ie to halt its progress
As this study is a Phase I study focused on tolerability and safety efficacy will be assessed in an exploratory manner
Long-term safety and behavior of the immune response to AADvac1 over time are the main points of interest
AADvac1 is a vaccine directed against pathologically modified Alzheimer tau protein that is the main constituent of neurofibrillary tangles NFTs and is intended to be a disease-modifying treatment for Alzheimers disease ie to halt its progress
As this study is a Phase I study focused on tolerability and safety efficacy will be assessed in an exploratory manner
Detailed Description:
AADvac1 is a candidate therapeutic vaccine for Alzheimers disease that targets misfolded tau protein a common denominator of neurofibrillary pathology Based on preclinical results the intervention is expected to reduce the number of neurofibrillary tangles remove hyperphosphorylated tau protein and reduce the amount of oligomerized and insoluble pathological tau in the brain to halt the spread of neurofibrillary pathology through the brain and thus prevent associated cognitive decline
The vaccines antigenic determinant is a synthetic peptide derived from a tau protein sequence which is coupled to keyhole limpet hemocyanin KLH and uses aluminum hydroxide Alhydrogel as an adjuvant
At present AADvac1 is intended as an active immunotherapy for patients with diagnosed Alzheimers disease AD According to need patients will receive additional immunization doses beyond those administered in the preceding pase 1 trial the raised titers of therapeutic antibodies and possible benefits of the treatment can extend beyond the duration of the study
Because of the central role of pathological misfolded tau protein in the etiology of AD the vaccine is expected to be more effective than active or passive immunotherapies aiming to eliminate the amyloid β plaques that have been clinically investigated so far
The vaccines antigenic determinant is a synthetic peptide derived from a tau protein sequence which is coupled to keyhole limpet hemocyanin KLH and uses aluminum hydroxide Alhydrogel as an adjuvant
At present AADvac1 is intended as an active immunotherapy for patients with diagnosed Alzheimers disease AD According to need patients will receive additional immunization doses beyond those administered in the preceding pase 1 trial the raised titers of therapeutic antibodies and possible benefits of the treatment can extend beyond the duration of the study
Because of the central role of pathological misfolded tau protein in the etiology of AD the vaccine is expected to be more effective than active or passive immunotherapies aiming to eliminate the amyloid β plaques that have been clinically investigated so far
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-004499-36 | EUDRACT_NUMBER | None | None |