Ignite Creation Date:
2024-05-06 @ 7:39 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02579252
Status:
COMPLETED
Last Update Posted:
2019-11-14
First Post:
2015-10-09
Brief Title:
24 Months Safety and Efficacy Study of AADvac1 in Patients With Mild Alzheimers Disease
Sponsor:
Axon Neuroscience SE
Organization:
Axon Neuroscience SE
Study Overview
Official Title:
A 24 Months Randomised Placebo-controlled Parallel Group Double Blinded Multi Centre Phase 2 Study to Assess Safety and Efficacy of AADvac1 Applied to Patients With Mild Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2019-11
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:
ADAMANT
Brief Summary:
This study evaluates the safety and efficacy of AADvac1 in the treatment of patients with mild Alzheimers disease
60 of participants will receive AADvac1 and 40 of participants will receive placebo
60 of participants will receive AADvac1 and 40 of participants will receive placebo
Detailed Description:
Alzheimers disease AD 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
Currently available treatments are designed to compensate for the neurotransmitter loss caused by the disease without affecting the disease process itself
AADvac1 is designed to raise antibodies against pathological tau protein the primary constituent of neurofibrillary pathology in AD 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
Currently available treatments are designed to compensate for the neurotransmitter loss caused by the disease without affecting the disease process itself
AADvac1 is designed to raise antibodies against pathological tau protein the primary constituent of neurofibrillary pathology in AD 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?:
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 |
|---|---|---|---|
| 2015-000630-30 | EUDRACT_NUMBER | None | None |