Alzheimer Disease Clinical Trial
Official title:
CSF1R PET Probe [18F]CSF-23 in Alzheimer's Disease Brain Imaging
To explore the diagnostic value of [18F]CSF-23 brain imaging for CSF1R expression in Alzheimer's disease. PET imaging with this PET tracer was used to assess the role and expression of CSF1R in AD and to evaluate the level and safety of abnormal present imaging.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | September 14, 2024 |
Est. primary completion date | June 16, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 80 Years |
Eligibility | Inclusion Criteria: - Non-diseased controls: 1. Between 60 and 80 years of age; gender is not limited. 2. Cognitively normal as determined by the investigator through testing, with an MMSE score greater than 25 and no cognitive domain impairment. They had a negative Aß image. 3. No neurological diseases, major chronic diseases, malignant tumors, or acute infectious diseases, as determined by the investigator. 4. Written informed consent must be signed by the subject or his/her legal guardian or caregiver. 5. Blood routine: white blood cell count (WBC) 4~10×109/L; platelet (PLT) 100~300×109/L; hemoglobin (HB) 120~160 g/L; renal function: serum creatinine less than or equal to the upper limit of the normal range; hepatic function: bilirubin, AST (SGOT)/ALT (SGPT) less than or equal to the upper limit of the normal range; Electrocardiogram: no significant abnormalities. 6. No neurological diseases, major chronic diseases, malignant tumors, or acute infectious diseases, as confirmed by the investigator; no family history of neurodegenerative movement disorders, and no family history of neurological disorders related to movement disorders. 7. Willingness and ability to cooperate with all programs of this study. AD patients: 1. Age between 60 and 80 years old; gender is not limited. 2. Patients meet the 2011 NIA-AA diagnostic criteria for red AD patients and have positive Aß images. 3. Brain MRI supported the diagnosis of AD and there was no evidence of other neurological diseases. 4. No neurological diseases, major chronic diseases, malignant tumors or acute infectious diseases, etc., as confirmed by the investigator. 5. Written informed consent must be signed by the subject or his/her legal guardian or caregiver. 6. Blood routine: white blood cell count (WBC) 4~10×109/L; platelet (PLT) 100~300×109/L; hemoglobin (HB) 120~160 g/L; renal function: serum creatinine less than or equal to the upper limit of the normal range; hepatic function: bilirubin, AST (SGOT)/ALT (SGPT) less than or equal to the upper limit of the normal range; ECG: no significant abnormalities. 7. No neurological diseases, major chronic diseases, malignant tumors, or acute infectious diseases, as confirmed by the investigator; no family history of neurodegenerative movement disorders, and no family history of neurological disorders related to movement disorders. 8. Willingness and ability to cooperate with all programs of this study. Exclusion Criteria: - Subjects meeting any of the following criteria will be excluded from the study: 1. Severe hepatic or renal insufficiency; 2. Participation in other research protocols or clinical care within the past year, in addition to the radiation exposure expected from participation in this clinical study, which has resulted in radiation exposure in excess of an effective dose of 50 mSv. 3. Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range. 4. History of serious surgery in the last month. 5. Participation in other clinical trials during the same period. |
Country | Name | City | State |
---|---|---|---|
China | Huashan Hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Huashan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete PET imaging | To assess the diagnostic value of [18F]CSF-23 brain imaging for CSF1R expression in Alzheimer's disease. | 90mins from time of injection |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04079803 -
PTI-125 for Mild-to-moderate Alzheimer's Disease Patients
|
Phase 2 | |
Completed |
NCT04044495 -
Sleep, Rhythms and Risk of Alzheimer's Disease
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Recruiting |
NCT04520698 -
Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease
|
N/A | |
Active, not recruiting |
NCT04606420 -
Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease
|
N/A | |
Recruiting |
NCT05820919 -
Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase
|
N/A | |
Terminated |
NCT03672474 -
REGEnLIFE RGn530 - Feasibility Pilot
|
N/A | |
Completed |
NCT03430648 -
Is Tau Protein Linked to Mobility Function?
|
||
Recruiting |
NCT04949750 -
Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease
|
N/A | |
Recruiting |
NCT04522739 -
Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease
|
Phase 4 | |
Recruiting |
NCT05557409 -
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation
|
Phase 3 | |
Recruiting |
NCT05288842 -
Tanycytes in Alzheimer's Disease and Frontotemporal Dementia
|
||
Completed |
NCT06194552 -
A Multiple Dose Study of the Safety and Pharmacokinetics of NTRX-07
|
Phase 1 | |
Completed |
NCT03239561 -
Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants
|
Early Phase 1 | |
Completed |
NCT03184467 -
Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients
|
Phase 2 | |
Active, not recruiting |
NCT03676881 -
Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
|
||
Terminated |
NCT03487380 -
Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease
|
N/A | |
Completed |
NCT05538455 -
Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases
|
N/A | |
Recruiting |
NCT05328115 -
A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease
|
Phase 1 | |
Completed |
NCT05562583 -
SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support
|
N/A |