Alzheimer Disease Clinical Trial
Official title:
Cross-sectional Validation and Longitudinal Study of Tau Protein and SV2a Imaging in Patients With Tau Protein-related Diseases and Normal Controls
Tau protein has been identified as one of the key pathological features of Tau proteinopathies, such as Alzheimer's disease (AD), progressive supranuclear palsy (PSP), frontotemporal dementia (FTD). Tau protein-targeted PET imaging can detect the amount and distribution of Tau protein deposition in human body, and has great research and application value in the diagnosis and evaluation of Tau protein disease. This study will be the first to introduce a complete quantitative, repeatable detection and analysis method in China. For the SV2a tracer [18F]MNI-1126, cross-sectional evaluation of its imaging in patients with Tau protein-related diseases and normal controls will be carried out. Later, longitudinal clinical symptoms and two tracers will be evaluated in patients with Tau protein-related diseases and normal controls.([18F]APN1607 and [18F]MNI1126) Imaging follow-up to explore longitudinal changes in brain Tau protein deposition and synaptic density in Tau protein-related diseases, thus providing support for future clinical drug trials using imaging biomarkers.
Status | Recruiting |
Enrollment | 155 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility | Inclusion Criteria: - Males and females aged 40 to 80 years. - Females have no fertility due to surgery or at least one year after menopause. Otherwise, pregnancy tests should be conducted during screening and every scan visit and should be negative. Males with fertility must use two methods of contraception during the study period and one of them should be barrier contraception. No sperm donation is allowed during the study period and within 90 days after the completion of this study. - The subject and the subject's legally authorized representative or caregiver should be willing and able to cooperate during the whole research process. According to the judgement of the researcher, there can be a research companion who has regular and sufficient contact with the subjects (spend more than 10 hours a week together). The companion can provide accurate information about the cognitive and functional aspects of the subject, and agrees to accompany the subjects and provide relevant information during the visits. Research companions must be confirmed by researchers that they have sufficient cognitive ability to accurately report subjects' behavior, cognition and function, and can accompany throughout the whole research process with subjects. - Researchers believe that the subject can complete all the relevant contents of this study. Exclusion Criteria: - Current or prior history of any alcohol or drug abuse within the past 3 years (self report). - Laboratory tests or ECG with clinically significant abnormalities and/or clinically significant unstable medical illness. - Radiation exposure received from clinical care prior participation in the last year, combined with that from the present study, exceeds an effective dose of 50 mSV. - Pregnant, lactating or breastfeeding or intention to become pregnant. - Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency (including a positive HIV result), pulmonary, or other disorder or disease. Stable, treated chronic medical conditions like hypertension, hypercholesterolemia, diabetes mellitus, non-metastatic dermatologic or prostatic cancer, etc. are acceptable as long as they do not, in the investigator's opinion, contribute to cognitive dysfunction or limit participation in study procedures. - In the opinion of the investigator, unsuitable to complete lumbar puncture. For example: history of vertebral deformities, major lumbar back surgery, clinically significant back pain, clinically significant abnormal x-ray, and/or injury or taking blood thinners or lab results that would preclude the subject/patient participation or CSF collection during study. - MRI exclusion criteria include: findings that may impact cognition such as significant evidence of cerebrovascular disease (more than two lacunar infarcts, any territorial infarct >1cm3, or deep white matter abnormality corresponding to an overall Fazekas scale of 3, with at least one confluent hyperintense lesion on the FLAIR sequence that is =20 mm in any dimension), infectious disease, space-occupying lesion, normal pressure hydrocephalus, CNS trauma, or any other structural abnormality that may impact cognition. - Veins are not suitable for repeated puncture. - Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI. - Daily treatment with anticholinergic antidepressants, typical antipsychotics, or barbiturates, daily treatment with benzodiazepines, opiates, or opioids; treatment with soporifics, stimulants, atypical antipsychotics, centrally acting anticholinergic antihistamines, or centrally acting anticholinergic antispasmodics is prohibited, unless administered intermittently and on a short-term basis and not used within 5 half-lives prior to screening or any neurocognitive assessment. - Treatment with soporifics, stimulants, atypical antipsychotics, centrally acting anticholinergic antihistamines, or centrally acting anticholinergic antispasmodics is prohibited unless (a) administered daily that initiation or discontinuation of therapy or dose change does not occur within 5 half-lives prior to screening or at any point during the study, or (b) administered intermittently and on a short-term basis and not used within 5 half-lives prior to screening or any neurocognitive assessment. - Treatment with any therapeutic molecule or treatment that targets Aß or Tau within 12 months prior to screening. - Have participated in a clinical trial within 30 days prior to screening or within 5 half-lives since last administration of investigational drug (whichever is greater). - Researchers consider that other diseases or causes might prevent subjects from completing the entire study. - Others that do not meet the specific inclusion/exclusion criteria of each part of this study. |
Country | Name | City | State |
---|---|---|---|
China | Xuanwu Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Xuanwu Hospital, Beijing | Biogen, H. Lundbeck A/S, Hangzhou G-Bio Biotechnology Co., Ltd, Hoffmann-La Roche, Millennium Pharmaceuticals, Inc., XINGIMAGING LLC |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The difference of Tau protein deposition and SV2a protein between patients with Tau protein-related diseases and healthy controls | through the distribution characteristics, time activity curves and kinetic parameters of the tracers in different populations, and to find out the key imaging parameters related to clinical symptoms. | March 2020 to December 2022. | |
Primary | To evaluate the longitudinal changes of Tau deposition and SV2a in patients with Tau-related diseases and healthy volunteers | Changes in each SUVR value or Tau and SV2a distribution were observed in subjects and healthy controls with different diseases | March 2020 to December 2022. | |
Primary | To evaluate the correlation between the longitudinal changes of the deposition of Tau and SV2a | clinical symptoms, MRI and serum biomarkers in patients with Tau-related diseases and healthy volunteers. | March 2020 to December 2022. | |
Primary | AE events | AE events after the subject scan were determined to evaluate the safety of [18F]APN-1607 and [18F]MNI-1126. | March 2020 to December 2022. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04044495 -
Sleep, Rhythms and Risk of Alzheimer's Disease
|
N/A | |
Completed |
NCT04079803 -
PTI-125 for Mild-to-moderate Alzheimer's Disease Patients
|
Phase 2 | |
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 |
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 |
NCT04949750 -
Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease
|
N/A | |
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 |