Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06182085
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2023-11-29
Brief Title:
Study to Assess Safety and Efficacy of PRI-002 in Patients With MCI to Mild Dementia Due to Alzheimers Disease AD
Sponsor:
PRInnovation GmbH
Organization:
PRInnovation GmbH
Study Overview
Official Title:
Randomised Double-blind Placebo-controlled Study to Assess Safety and Efficacy of PRI-002 in Patients With MCI to Mild Dementia Due to Alzheimers Disease AD PRImus-AD
Status:
RECRUITING
Status Verified Date:
2024-10
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:
PRImus-AD
Brief Summary:
Alzheimers disease AD is the most common form of dementia In the brains of people with AD certain small substances stick together This leads to changes in thinking and behaviour The company PRInnovation is developing a new treatment for Alzheimers disease called PRI-002 It is thought that PRI-002 can cut the sticked substances back into small pieces That would reduce the effects of Alzheimers disease In the current study the investigators examine whether PRI-002 is safe and effective in participants with mild cognitive impairment MCI or mild dementia due to AD
Detailed Description:
Alzheimers disease AD is a progressive neurodegenerative disorder and the most common form of dementia The post-mortem pathology of AD is mainly characterised by neurodegeneration as well as extracellular amyloid plaques and intracellular neurofibrillary tangles Research suggests that the amyloid-β-peptide Aβ aggregation plays a major role in the development of AD while Aβ oligomers are thought to be the most toxic species Therefore various strategies to develop AD therapeutics address Aβ and some examples include trying to reduce its formation inhibit its aggregation to fibrils or enhancing its clearance
PRI-002 is being investigated as a possible treatment for cognitive impairment due to AD PRI-002 is an all D-amino acid peptide all-D-peptide consisting of a rationally designed primary structure resulting in efficient removal of Aβ oligomers PRI-002 specifically aims to eliminate neurotoxic Aβ oligomers by disassembling prion-like behaving Aβ oligomers into non-toxic Aβ monomer units This therapeutic principle is new and unique and differs from that of other amyloid related drug candidates currently in clinical development which aim to increase the degradation rate of different Aβ species
The current trial is a Phase 2 proof-of-concept study to further investigate the safety and efficacy of PRI-002 in patients with mild cognitive impairment MCI or mild dementia due to AD
PRI-002 is being investigated as a possible treatment for cognitive impairment due to AD PRI-002 is an all D-amino acid peptide all-D-peptide consisting of a rationally designed primary structure resulting in efficient removal of Aβ oligomers PRI-002 specifically aims to eliminate neurotoxic Aβ oligomers by disassembling prion-like behaving Aβ oligomers into non-toxic Aβ monomer units This therapeutic principle is new and unique and differs from that of other amyloid related drug candidates currently in clinical development which aim to increase the degradation rate of different Aβ species
The current trial is a Phase 2 proof-of-concept study to further investigate the safety and efficacy of PRI-002 in patients with mild cognitive impairment MCI or mild dementia due to AD
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