An observational study in Alzheimer's Disease Dementia, sponsored by Tianjin Anding Hospital. Recruiting at 1 site in China. Open to participants aged 55 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Tianjin Anding Hospital · Observational
Among 260 studies in Alzheimer Disease with a site in China — 150 open to participants now, 162 under way, 21 of them phase 3. Alzheimer Disease · China.
Among the 260 studies in Alzheimer Disease with a site in China, this one is the 63rd largest by planned enrollment of the 84 observational ones, is one of 36 that started in 2026, is one of 84 observational ones, reaches primary completion later than 140 of the 161 other live ones, and was the 249th registered.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 814 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →150 of the 260 studies in Alzheimer Disease with a site in China are open now, in 12 countries. Each count lists the studies.
Of the 641 Alzheimer Disease studies recruiting now, 283 (44%) set no upper age limit and 54 (8%) stop at 75 or younger; 34 take children under 18; 283 take healthy volunteers.
This study: 55 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →260 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 36 started in 2026.
Median enrollment 100 across the 176 interventional studies, 566 across the 84 observational. Of the 65 that completed or were terminated, 16 (25%) have results posted.
68 of 260 have an industry lead sponsor. The 10 most frequent:
Tianjin Anding Hospital is the lead sponsor of 24 studies on the registry; 10 are open to participants now.
Tianjin Anding Hospital has 1 study filed under Alzheimer Disease — fewer than ten, so there is no comparison to draw.
45 of the studies in Alzheimer Disease with a site in China that are under way reach primary completion within a year, 8 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06585787Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyA Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4) | 2026-11-24 |
| NCT07422857Phase 3JYAMS PET Research & Development LimitedEvaluate the Use of [18F]-APN-1607 PET in Subjects With AD-related Cognitive Impairment and Subjects With Normal Cognitive Function | 2026-12-01 |
| NCT06126224Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyA Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2) | 2026-12-09 |
| NCT03887455Phase 3Eisai Inc.A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease | 2026-12-31 |
| NCT07323914Phase 3Xuanwu Hospital, BeijingClinical Analgesic Management in Dementia | 2027-01-01 |
Among the 260 studies in Alzheimer Disease with a site in China, from their registry updates:
This is a prospective, observational cohort study. The primary objective is to characterize the clinical features and mechanisms of behavioral and psychological symptoms of dementia (BPSD) in patients with probable Alzheimer's disease (AD) who are plasma p-Tau217 negative, and to compare them with p-Tau217-positive patients. After grouping participants by an authoritative p-Tau217 cutoff value, the negative and positive groups will be systematically compared across all 12 domains of the Neuropsychiatric Inventory (NPI). Participants will be followed up at 6, 12, and 18 months to compare the incidence of cognitive decline, new-onset severe BPSD (hallucinations, agitation/aggression, depression, etc.), cerebrovascular events, and hospitalization between the two groups. As an exploratory objective, baseline BPSD domains combined with imaging (white matter hyperintensity burden) and blood biomarkers (NfL, IL-6, GFAP, etc.) will be used to construct a simple prognostic risk-stratification model within the negative group and to validate its predictive performance. The study aims to improve the recognition of non-AD-driven dementia with overlapping clinical presentations, thereby informing clinical management and care planning in the era of biology-based AD diagnosis.
This is a prospective observational study conducted at Tianjin Anding Hospital. A total of patients with probable Alzheimer's disease will be enrolled over a 3-year recruitment period. Participants will be stratified into p-Tau217-negative, p-Tau217-positive and grey-zone groups according to validated plasma p-Tau217 cut-off values. Baseline assessments include demographic data, physical examination, neuropsychological scales such as MMSE, MoCA, NPI, CDR, ADL, CBI and CGI, as well as brain MRI and Aβ-PET imaging. Peripheral blood samples will be collected for detection of Aβ42, Aβ40, Aβ42/40 ratio, p-Tau217, NfL, GFAP and ApoE genotyping. Subjects will receive routine clinical management without restricted study-specific medications, and follow-up evaluations will be performed at 6-, 12- and 18-month time-points. The primary objective is to compare differences across all 12 dimensions of the Neuropsychiatric Inventory (NPI) between p-Tau217-negative and p-Tau217-positive groups, and to compare the incidence of cognitive decline, new-onset severe behavioral and psychological symptoms of dementia (BPSD), cerebrovascular events and hospitalizations during follow-up. The exploratory objective is to develop a simple prognostic risk stratification model combining baseline BPSD profiles, white-matter hyperintensity burden on imaging and blood biomarkers including NfL, IL-6 and GFAP among p-Tau217-negative participants, with subsequent validation required for this exploratory analysis. Eligible participants are aged 50-90 years, meeting 2011 NIA-AA criteria for probable Alzheimer's disease dementia, with MMSE score \<24, CDR>0.5 and Hachinski Ischemic Scale ≤4. Subjects with other definite neurocognitive disorders, severe unstable systemic or neurological diseases will be excluded. This study has been approved by the Ethics Committee of Tianjin Anding Hospital. All participants or their legal guardians will provide written informed consent prior to any study-related procedures. All analyses will be performed based on collected longitudinal clinical, imaging and laboratory data.
Meet the diagnostic criteria for probable Alzheimer's disease dementia (probable AD) proposed by the National Institute on Aging and Alzheimer's Association (2011 NIA-AA)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1. Aged between 50 and 90 years, without gender restriction; 2. Meet the diagnostic criteria for probable Alzheimer's disease dementia (probable AD) proposed by the National Institute on Aging and Alzheimer's Association (2011 NIA-AA); 3. Mini-Mental State Examination (MMSE) score \< 24; 4. Clinical Dementia Rating (CDR) score \> 0.5;
Neuropsychiatric Inventory (NPI)
The total score ranges from 0 to 144. Higher scores indicate more severe neuropsychiatric/behavioral symptoms (worse outcome).
Time frame: 0Month、6Month、12Month、18Month
Mini-Mental State Examination（MMSE）
Score range: 0-30. Higher scores mean better outcome (better cognitive performance).
Time frame: 0Month、6Month、12Month、18Month
Montreal Cognitive Assessment（MoCA）
Score range: 0-30. Higher scores mean better outcome (superior cognitive performance).
Time frame: 0Month、6Month、12Month、18Month
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Dec 2029, 47 months after the start.
Of 364 non-industry observational studies under Alzheimer Disease, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 203. This study's planned 47 months is below that.
Counting every sponsor, half of 405 studies reached it within 67 months; a quarter within 35 and three quarters within 171.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Tianjin Anding Hospital