Study on Multimodal Imaging and Molecular Imaging Techniques in Degenerative Dementia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-85
SponsorRuijin Hospital
About this trial
This project is a multicenter observational study that establishes a longitudinal cohort of patients with Alzheimer's disease and other dementias based on neuroimaging, molecular imaging, biological and digital markers to explore new solutions such as dementia disease mechanism, diagnosis, condition evaluation, and prognosis assessment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged ≥50 and ≤85 years old, male or female;
Meet the diagnostic criteria for dementia or MCI;
Neuropsychological score: MMSE 15-28 points, CDR ≤ 1 point; ④ Patients and their families are informed and sign the informed consent form
Disqualifiers
The presence of other neurological diseases that may cause brain dysfunction (such as depression, brain tumors, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, brain trauma, normal intracranial pressure hydrocephalus, etc.);
The presence of other systemic diseases that may cause cognitive impairment (such as liver dysfunction, renal dysfunction, thyroid dysfunction, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.);
Suffering from a disease that makes it impossible to cooperate with cognitive examinations;
The presence of contraindications to MRI;
Trial population
The population in this study includes the cognitive impairment patients in Ruijin Hospital, Renji Hospital, The First Hospital of Zhejiang University School of Medicine, The First Hospital of China Medical University.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
The change of incidence of cognitive impairment
Number of participants who covert to AD or mild cognitive impairment (MCI) will be recorded to calculate the incidence.
Time frame
baseline, 1 year, 2 year, 3 year, 4 yearSecondary outcomes
1
The change of Mini-Mental State Examination (MMSE)
MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges from 0 to 30; lower score indicates greater disease severity.
Time frame
baseline, 1 year, 2 year, 3 year, 4 year2
The change of Montreal cognitive assessment-Basic (MoCA)
MoCA is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges from 0 to 30; lower score indicates greater disease severity.
Time frame
baseline, 1 year, 2 year, 3 year, 4 year3
The change of Auditory verbal learning test (AVLT)
AVLT is a screening instrument used to assess the function of memory. The score in long-term memory (N5) ranges from 0 to 12, with lower scores indicating greater disease severity.
Time frame
baseline, 1 year, 2 year, 3 year, 4 year4
The change of structural MRI
Structural MRI data will be acquired and analyzed through high-resolution T1-weighted MRI and diffusion tensor imaging (DTI).
Time frame
baseline, 1 year, 2 year, 3 year, 4 yearSponsors and contacts
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Source ClinicalTrials.gov