Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06177028
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-20
First Post:
2023-12-11
Brief Title:
MCLENA-2 A Phase II Clinical Trial for the Assessment of Lenalidomide in Patients With Mild Cognitive Impairment Due to Alzheimers Disease
Sponsor:
St Josephs Hospital and Medical Center Phoenix
Organization:
St Josephs Hospital and Medical Center Phoenix
Study Overview
Official Title:
MCLENA-2 A Phase II Clinical Trial for the Assessment of Biomarker Trajectory in Patients With Mild Cognitive Impairment Due to Alzheimers Disease Treated With Lenalidomide Amendment to IND 142121
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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:
None
Brief Summary:
This is a randomized double-blind placebo-controlled parallel group study The use of placebo is appropriate to minimize bias related to treatment expectations of the subject study partner and site investigator as well as to changes in the relationship between the subject and study partner that might occur with the initiation of treatment and expectation of improvement in motor symptoms or cognition Changes in subjectstudy partner interactions can impact subject mood and might introduce biases that cannot be quantified The double-blind use of placebo will also prevent bias in the clinical and scientific assessments
Detailed Description:
There are currently no FDA-approved medications indicated for the treatment of AD While inflammation is pervasive to many neurological disorders no clinical trial has yet demonstrated the efficacy of anti-inflammatory agents for AD Interestingly chronic peripheral low-grade inflammation is associated with aging and increases the risk for disease and mortality including AD Accumulating evidence indicates that nuclear factor-kappa B tumor necrosis factor alpha TNFα interleukins eg IL-1beta IL-2 and IL-6 and chemokines eg IL-8 are found elevated both in the blood and central nervous system CNS of AD patients These data confirm that inflammation plays a central role in the cause and effect of AD neuropathology
The immunomodulator anti-cancer agent lenalidomide is one of the very few pleiotropic agents that both lowers the expression of TNFα IL-6 IL-8 and increases the expression of anti-inflammatory cytokines eg IL-10 to modulate both innate and adaptive immune responses In the current project we aim to test the central hypothesis that lenalidomide reduces inflammatory and AD-associated pathological biomarkers in the blood and CSF For this we designed a 6-month Phase II double blind randomized two-armed parallel group placebo controlled and proof-of-mechanism clinical study in early symptomatic AD subjects ie amnestic mild cognitive impairment aMCI The effects of lenalidomide treatment will be assessed continuously for 26 weeks and 4 weeks washout total of 30 weeks
The immunomodulator anti-cancer agent lenalidomide is one of the very few pleiotropic agents that both lowers the expression of TNFα IL-6 IL-8 and increases the expression of anti-inflammatory cytokines eg IL-10 to modulate both innate and adaptive immune responses In the current project we aim to test the central hypothesis that lenalidomide reduces inflammatory and AD-associated pathological biomarkers in the blood and CSF For this we designed a 6-month Phase II double blind randomized two-armed parallel group placebo controlled and proof-of-mechanism clinical study in early symptomatic AD subjects ie amnestic mild cognitive impairment aMCI The effects of lenalidomide treatment will be assessed continuously for 26 weeks and 4 weeks washout total of 30 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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