early-onset and late-onset Alzheimers disease
Conditions
Interventions
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
5 Years to No maximum
Inclusion criteria
Inclusion criteria: Mild Cognitive Impairment (MCI) Inclusion Criteria (must meet all of the following conditions): 1. Meet the MCI diagnostic criteria of the National Institute on Aging-Alzheimer's Association (NIA-AA, 2024 edition). 2. Clinical Dementia Rating (CDR) score of 0.5. 3. MMSE: Score >=17 for those with 0 years of education, >=20 for those with =24 for those with >=7 years. 4. Prominent memory decline, possibly accompanied by impairment in other cognitive domains. 5. Insidious onset, gradual progression. 6. Does not meet dementia criteria. 7. Subjects have adequate audiovisual and language function, or can complete neuropsychological examinations after correction. 8. Subjects, guardians, and caregivers can complete relevant examinations and follow-up work. 9. Subjects voluntarily participate in this trial, and the subject and their legally responsible guardian/caregiver sign the informed consent form before the trial. 10. Subjects agree to have their blood samples collected for biomarker and other testing. 11. Age: >=5 years old. Sex: 50% male, 50% female. Alzheimer's Disease (AD) Inclusion Criteria (must meet all of the following conditions): 1. Age: >=5 years old. Sex: 50% male, 50% female. 2. Meet the AD diagnostic criteria of the National Institute on Aging-Alzheimer's Association (NIA-AA, 2024 edition). 3. CDR score of 0.5 or 1. 4. MMSE: Score =7 years. 5. Subjects have adequate audiovisual and language function, or can complete neuropsychological examinations after correction. 6. Subjects, guardians, and caregivers can complete relevant examinations and follow-up work. 7. Subjects voluntarily participate in this trial, and the subject and their legally responsible guardian/caregiver sign the informed consent form before the trial. 8. Subjects agree to have their blood samples collected for biomarker and other testing. Cognitively Normal Individuals Inclusion Criteria (must meet all of the following conditions): 1. Age: >=5 years old. Sex: 50% male, 50% female. 2. Normal cognitive function, no past or present history of mental or neurological diseases. Participants aged >=20 years undergo initial screening using the Mini-Mental State Examination (MMSE), with an MMSE score >26. 3. Subjects have adequate audiovisual and language function, or can complete neuropsychological examinations after correction. 4. Subjects, guardians, and caregivers can complete relevant examinations and follow-up work. 5. Subjects voluntarily participate in this trial, and the subject and their legally responsible guardian/caregiver sign the informed consent form before the trial. 6. Subjects agree to have their blood samples collected for biomarker and other testing.
Exclusion criteria
Exclusion criteria: Mild Cognitive Impairment (MCI) Exclusion Criteria (meeting any of the following conditions leads to exclusion): 1. Presence of neurological diseases that may significantly interfere with this study, including but not limited to: symptomatic neurodegenerative diseases, epilepsy, neuroimmunological diseases, brain tumors, cerebrovascular diseases, nervous system infections, etc. 2. Current or past history of schizophrenia, bipolar disorder; or currently active, untreated major depression; or presence of psychotic symptoms, significant irritability, or behavioral problems within the last 3 months that would affect study compliance. 3. Presence of other systemic diseases that can cause cognitive impairment, such as liver dysfunction, renal dysfunction, thyroid dysfunction, severe anemia, folate and vitamin B12 deficiency, specific infections (e.g., syphilis, HIV), alcohol and drug abuse, etc. 4. Presence of mental and neurodevelopmental retardation. 5. Presence of other known diseases that may lead to cognitive impairment. 6. Currently using the following medications: psychoactive drugs (e.g., antidepressants, neuroleptics, chronic anxiolytics, sedative-hypnotics), anticoagulants (e.g., warfarin, dabigatran, rivaroxaban, apixaban, except for lumbar puncture medications), medications for obsessive-compulsive disorder/attention deficit disorder, or any other medications explicitly prohibited by this study protocol. 7. Suffering from diseases that prevent cooperation with cognitive examination. 8. Refusal to undergo blood draw. 9. Pregnant or breastfeeding women. 10. Refusal to sign the informed consent form. 11. Other conditions deemed unsuitable for participation by the investigator. Alzheimer's Disease (AD) Exclusion Criteria (meeting any of the following conditions leads to exclusion): 1. Presence of neurological diseases that may significantly interfere with this study, including but not limited to: symptomatic neurodegenerative diseases, epilepsy, neuroimmunological diseases, brain tumors, cerebrovascular diseases, nervous system infections, etc. 2. Current or past history of schizophrenia, bipolar disorder; or currently active, untreated major depression; or presence of psychotic symptoms, significant irritability, or behavioral problems within the last 3 months that would affect study compliance. 3. Presence of other systemic diseases that can cause cognitive impairment, such as liver dysfunction, renal dysfunction, thyroid dysfunction, severe anemia, folate and vitamin B12 deficiency, specific infections (e.g., syphilis, HIV), alcohol and drug abuse, etc. 4. Presence of mental and neurodevelopmental retardation. 5. Presence of other known diseases that may lead to cognitive impairment. 6. Currently using the following medications: psychoactive drugs (e.g., antidepressants, neuroleptics, chronic anxiolytics, sedative-hypnotics), anticoagulants (e.g., warfarin, dabigatran, rivaroxaban, apixaban, except for lumbar puncture medications), medications for obsessive-compulsive disorder/attention deficit disorder, or any other medications explicitly prohibited by this study protocol. 7. Suffering from diseases that prevent cooperation with cognitive examination. 8. Refusal to undergo blood draw. 9. Pregnant or breastfeeding women. 10. Refusal to sign the informed consent form. 11. Other conditions deemed unsuitable for participation by the investigator. Cognitively Normal Individuals Exclusion Criteria (meeting any of th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma Aß42/40 ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| APOE e4 allele genotyping;plasma T-tau?P-tau181?P-tau217?NFL?GFAP; | — |
Countries
China
Contacts
Public ContactJIA Jianping
Xuanwu Hospital Capital Medical University
Outcome results
None listed