Ignite Creation Date:
2024-05-06 @ 10:09 AM
Last Modification Date:
2024-10-26 @ 12:25 PM
Study NCT ID:
NCT03174886
Status:
UNKNOWN
Last Update Posted:
2019-11-14
First Post:
2017-05-29
Brief Title:
A 24-month Phase 1 Pilot Study of AADvac1 in Patients With Non Fluent Primary Progressive Aphasia
Sponsor:
Axon Neuroscience SE
Organization:
Axon Neuroscience SE
Study Overview
Official Title:
A 24-month Randomised Parallel Group Single-blinded Multi-centre Phase 1 Pilot Study of AADvac1 in Patients With Non Fluent Primary Progressive Aphasia
Status:
UNKNOWN
Status Verified Date:
2019-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
AIDA
Brief Summary:
This study is a pilot trial evaluating the safety and immunogenicity of AADvac1 in patients with the non-fluent variant of Primary Progressive Aphasia
50 of participants will receive the 40 µg dosage of AADvac1 and 50 of participants will receive the 160 µg dosage of AADvac1 No placebo is used
50 of participants will receive the 40 µg dosage of AADvac1 and 50 of participants will receive the 160 µg dosage of AADvac1 No placebo is used
Detailed Description:
The non-fluent variant of Primary progressive Aphasia nfvPPA is a chronic progressive neurodegenerative disorder of the brain Over the course of the disease pathological proteins accumulate in the brain damaging neurons thus causing them to lose their connections and die
No treatments are currently available symptomatic medications are used off-label in nfvPPA
AADvac1 is designed to raise antibodies against pathological tau protein the primary constituent of neurofibrillary pathology which is the underlying cause of disease in 80 of nfvPPA cases These antibodies are expected to prevent tau protein from aggregating to facilitate the removal of tau protein aggregates and prevent the spreading of pathology slowing or halting the progress of the disease
No treatments are currently available symptomatic medications are used off-label in nfvPPA
AADvac1 is designed to raise antibodies against pathological tau protein the primary constituent of neurofibrillary pathology which is the underlying cause of disease in 80 of nfvPPA cases These antibodies are expected to prevent tau protein from aggregating to facilitate the removal of tau protein aggregates and prevent the spreading of pathology slowing or halting the progress of the disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2017-000643-41 | EUDRACT_NUMBER | None | None |