Ignite Creation Date:
2024-07-17 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489548
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-05-28
Brief Title:
Assessment of Foralumab Safety and Modulation of Microglial Activation
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Assessment of Foralumab Safety and Modulation of Microglial Activation Evaluated by PET Imaging in Patients With Early Symptomatic Alzheimers Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 phase 2a study will research the safety and tolerability of Foralumab a human anti-CD3 antibody An antibody is a molecule secreted by the immune system These molecules are created to identify a specific pathogen Previous data on experimental mice has suggested that Foralumab increases the immune system activity in the brain to reduce the inflammation of microglia the brains main immune cells This combination of increased immune reactivity and less microglia inflammation may improve the immune response throughout the brain Alzheimers disease and other forms of dementia are characteristically known for the build-up of certain proteins in the brain This trial will evaluate whether nasal Foralumab can improve cognition in participants with mild cognitive impairment due to early Alzheimers or dementia
The trial will ask participants to administer Foralumab nasally three times a week for eight weeks The administration will occur intermittently with breaks between each dosing cycle Participants will also receive brain scans Amyloid PET and MRI undergo cognitive testing blood draws and physical neurological and nasal exams Volunteers are expected to remain in the trial for six months
The trial will ask participants to administer Foralumab nasally three times a week for eight weeks The administration will occur intermittently with breaks between each dosing cycle Participants will also receive brain scans Amyloid PET and MRI undergo cognitive testing blood draws and physical neurological and nasal exams Volunteers are expected to remain in the trial for six months
Detailed Description:
Preliminary data has shown that Foralumab a human anti-CD3 antibody may improve cognition in APPPS1and 3xTg mouse models of AD Nasal Foralumab has been given to healthy volunteers with progressive multiple sclerosis MS When given nasally for five consecutive days doeses up to 250 µg are well-tolerated
This is a randomized double-blind placebo-controlled study assessing two dose levels of nasal foralumab 50 µgdosing day and 100 µgdosing day or placebo given in three-week treatment cycles A treatment cycle is defined as Investigational Product IP dosing on Monday Wednesday and Friday for two consecutive weeks followed by a one-week pause in dosing or a rest week All treatment cycles follow the identical dosing regimen Randomization will be 31 Active to Placebo
Two cohorts of eight 8 subjects each will be enrolled in this study and enrollment in these cohorts will be staggered Both cohorts Cohort A and Cohort B will consist of six 6 subjects who will complete three months 4 cycles of active treatment and two 2 subjects who receive Placebo treatment Enrollment into Cohort B may begin once all subjects in Cohort A complete 2 cycles of treatment
Subjects will be screened and enrolled at the Center for Alzheimer Research and Treatment CART Initial treatment visits will occur in the Center for Clinical Investigation CCI with follow-up visits occurring in CART Both centers are in the Building for Transformative Medicine Brigham and Womens Hospital BWH at 60 Fenwood Road Boston MA 02115
Subjects will undergo screening procedures including laboratory studies hematology clinical chemistry CRP EBV serology HIV testing Hepatitis B and Hepatitis C vital signs cognitive testing and a complete physical exam by the physician investigator or a mid-level practitioner and a detailed neurologic examination performed by a neurologist Each subject must have normal laboratory tests or results must be in a clinically acceptable range in the opinion of the Investigator An additional screening visit will consist of an amyloid PET scan if subjects do not already have those results prior to screening Prior to each treatment cycle and at the end of treatment an ENT physician will conduct a nasal exam and safety blood labs will be collected At baseline and end of treatment each subject will have blood samples collected for immunological study and undergo an MRI and a microglial PET scan Blood samples for immunologic studies will be collected at baseline and after 3 months of treatment A lumbar puncture will be performed at the screening visit and after 3 months of treatment to assess for changes in amyloid and tau
This is a randomized double-blind placebo-controlled study assessing two dose levels of nasal foralumab 50 µgdosing day and 100 µgdosing day or placebo given in three-week treatment cycles A treatment cycle is defined as Investigational Product IP dosing on Monday Wednesday and Friday for two consecutive weeks followed by a one-week pause in dosing or a rest week All treatment cycles follow the identical dosing regimen Randomization will be 31 Active to Placebo
Two cohorts of eight 8 subjects each will be enrolled in this study and enrollment in these cohorts will be staggered Both cohorts Cohort A and Cohort B will consist of six 6 subjects who will complete three months 4 cycles of active treatment and two 2 subjects who receive Placebo treatment Enrollment into Cohort B may begin once all subjects in Cohort A complete 2 cycles of treatment
Subjects will be screened and enrolled at the Center for Alzheimer Research and Treatment CART Initial treatment visits will occur in the Center for Clinical Investigation CCI with follow-up visits occurring in CART Both centers are in the Building for Transformative Medicine Brigham and Womens Hospital BWH at 60 Fenwood Road Boston MA 02115
Subjects will undergo screening procedures including laboratory studies hematology clinical chemistry CRP EBV serology HIV testing Hepatitis B and Hepatitis C vital signs cognitive testing and a complete physical exam by the physician investigator or a mid-level practitioner and a detailed neurologic examination performed by a neurologist Each subject must have normal laboratory tests or results must be in a clinically acceptable range in the opinion of the Investigator An additional screening visit will consist of an amyloid PET scan if subjects do not already have those results prior to screening Prior to each treatment cycle and at the end of treatment an ENT physician will conduct a nasal exam and safety blood labs will be collected At baseline and end of treatment each subject will have blood samples collected for immunological study and undergo an MRI and a microglial PET scan Blood samples for immunologic studies will be collected at baseline and after 3 months of treatment A lumbar puncture will be performed at the screening visit and after 3 months of treatment to assess for changes in amyloid and tau
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HLW-AD-NAS-003 | OTHER | None | None |