Alzheimer’s disease
Conditions
Interventions
Anti-ß-amyloid monoclonal antibody treatment group:None
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
50 Years to 90 Years
Inclusion criteria
Inclusion criteria: Anti-ß-amyloid monoclonal antibody treatment group: AD-related MCI: 1. Meet the core clinical criteria for AD-related mild cognitive impairment (MCI) according to the National Institute on Aging-Alzheimer's Association (NIA-AA) 2011 guidelines. 2. Have a CDR global score of 0.5 at screening and baseline. 3. Have a history of subjective memory decline that has developed gradually over at least one year or more, with slow progression, confirmed by a family member or caregiver. Mild AD-related dementia: 4. Meet the core clinical criteria for probable AD dementia according to the NIA-AA 2011 guidelines. 5. Have a CDR global score between 0.5 and 1.0 at screening and baseline. Key inclusion criteria applicable to all participants in the anti-ß-amyloid monoclonal antibody treatment group: 6. Show positive brain amyloid burden as demonstrated by Aß(AV45)-PET imaging. 7. Receive treatment with an anti-ß-amyloid monoclonal antibody. 8. Be accompanied by a designated caregiver at each follow-up visit. 9. Provide written informed consent. If the investigator determines that the participant lacks capacity for informed consent, consent must be obtained from a legally appointed representative in accordance with local laws, regulations, and customs; written informed consent from the legal representative shall be obtained (the definition of legal representation and capacity for consent shall be determined based on applicable local laws and regulations). The participant must be willing and able to comply with all aspects of the study protocol. Conventional treatment group: AD-related MCI: 1. Meets the core clinical criteria for AD-related MCI as defined by the National Institute on Aging-Alzheimer's Association (NIA-AA) in 2011. 2. At the screening and baseline stages, the CDR overall score is 0.5. 3. Has a history of subjective memory decline that gradually developed over at least one year or more and progresses slowly; this must be confirmed by a family member or caregiver. Mild AD dementia: 4. Meets the core clinical criteria for probable AD dementia as defined by the National Institute on Aging-Alzheimer's Association (NIA-AA) in 2011. 5. At the screening and baseline stages, the CDR overall score is 0.5 to 1.0. Key inclusion criteria for all subjects in the conventional treatment group: 6. Show positive brain amyloid lesions as indicated by Aß (AV45)-PET. 7. Receive conventional symptomatic treatment for Alzheimer's disease. 8. Have a confirmed caregiver at each follow-up visit. 9. Provide a written informed consent. If the subject is considered by the investigator to lack the ability to give informed consent, then the subject's consent should be obtained in accordance with local laws, regulations, and customs, and the written informed consent of the legal representative should be obtained (the definition and consent ability of legal representation should be determined according to applicable local laws and regulations). Willing and able to comply with all aspects of the protocol.
Exclusion criteria
Exclusion criteria: Anti-ß-amyloid monoclonal antibody treatment group: 1. Head MRI and SWI sequence examination reveals: more than 4 microbleeds (defined as the maximum diameter <= 10 mm); a single bleed with a maximum diameter over 10 mm; presence of cortical hemosiderin deposition; evidence of vasogenic edema; evidence of brain contusion, brain atrophy, vascular malformations or infectious lesions; evidence of multiple lacunar infarctions or strokes involving major vascular regions, severe small vessel disease or severe white matter lesions; intracranial mass lesion; or brain tumor (lesions diagnosed as meningiomas or arachnoid cysts with a maximum diameter less than 1 cm do not need to be excluded). 2. The patient presents with severe infusion reaction, or clinical features of meningeal encephalitis, or severe hypersensitivity reaction, and is unable to continue using Loxapine treatment. 3. Within the past 1 year, there is a history of drug abuse or drug, alcohol dependence. 4. Patients with severe neurological and mental disorders or those with a previous severe neurological history or history of brain trauma, brain surgery. 5. Patients with severe underlying diseases or physical diseases or diseases that may affect assessment (such as hearing and vision impairments, etc.). 6. Suffering from other severe neurodegenerative systemic diseases. 7. Installed intracranial stents, cardiac pacemakers, coronary stents, cochlear implants and other implanted metallic materials, or have claustrophobia and cannot undergo MR examination. 8. Other situations that researchers consider not suitable for inclusion. Conventional treatment group: 1. Has a history of drug abuse or drug/alcohol dependence in the past 1 year. 2. Patients with severe neuropsychiatric disorders or a previous history of severe neurological diseases or brain trauma, brain surgery. 3. Has severe underlying diseases or physical illnesses that may affect the assessment (such as hearing or vision impairments, etc.). 4. Suffers from other severe neurodegenerative systemic diseases. 5. Has implanted metallic materials such as intracranial stents, cardiac pacemakers, coronary stents, or cochlear implants, or has claustrophobia and is unable to undergo MR examination. 6. Other situations deemed unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TSPO(DPA714)-PET SUVR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mini-Mental State Examination Scores;Plasma inflammatory factors levels;Montreal Cognitive Assessment Scores;Aß(AV45)-PET SUVR;Tau(AV1451)-PET SUVR;Plasma AD pathological markers;Incidence of adverse reactions;Clinical Dementia Rating (CDR) scale; | — |
Countries
China
Contacts
Public ContactTang Huidong
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed