ClinicalTrials.gg
Not yet recruitingNCT07629531Updated Jun 5, 2026

Applied Research on a Non-pharmacological Intervention Program for Older Adults With Subjective Cognitive Decline

An interventional study of non-pharmacological interventions and Waiting List in Non-Pharmacological Interventions, sponsored by China Medical University, China. Not yet recruiting. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-06-05.

Sponsored by China Medical University, China · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
218
Allocation
Randomized
Ages
60 Years to 85 Years
Sex
All
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Study summary

This study aims to verify the short-term and long-term effects of a group-based non-pharmacological intervention program for community-dwelling older adults with subjective cognitive decline, and to evaluate its implementation outcomes, through a rigorously designed cluster randomized controlled trial.

Read the detailed description

This study adopts a cluster randomized controlled design to implement a group-based non-pharmacological intervention for older adults with subjective cognitive decline. The effects of the intervention on global cognitive function, episodic memory, executive function, attention, language function, subjective memory function, anxiety, depression, social participation, gait speed, physical activity level, and healthy lifestyle behaviors will be evaluated. In addition, implementation outcomes will be assessed based on the RE-AIM framework and the CFIR framework.

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Conditions studied

  • Non-Pharmacological Interventions
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In context

Lead sponsor

China Medical University, China is the lead sponsor of 94 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria Aged ≥60 Community dwelling Subjective memory decline, confirmed by Subjective Cognitive Decline Questionnaire(SCD-Q9)≥5 (MoCA) scores ≥19, 22, or 24 for participants who had primary school, middle school, or higher education, respectively Overall intact activities of daily living No planned exercise or cognitive intervention activities within the past six months Voluntary participants who will be informed of the study objectives by the researcher and will sign the form.

Exclusion Criteria Any other neurodegenerative diseases (such as mild cognitive impairment, dementia, Parkinson's disease, stroke, etc.) Any severe or unstable internal medical conditions (i.e., unstable or severe asthma or heart disease, liver and kidney diseases, uncontrolled hypertension, severe metabolic diseases, etc.) Severe depressive, anxiety or other psychiatric disorders Movement Those currently participating in other research trials.

Terms in these criteria, in plain language(3)

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.

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.

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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
218 participants (estimated)

Study arms

  • Experimental
    Non-Pharmacological Interventions

    Non-Pharmacological Interventions

    Other: non-pharmacological interventions

  • Other
    Waiting List Control Group

    To ensure ethical fairness, the same intervention program will subsequently be provided to the waitlist control group after positive effects are confirmed in the intervention group.

    Other: Waiting List

Interventions

  • Othernon-pharmacological interventions

    6 components(social intercourse, cognitive interventions, physical activities interventions, rational diet, understanding and risk management of diseases, emotion management)

  • OtherWaiting List

    To ensure ethical fairness, the same intervention program will subsequently be provided to the waitlist control group after positive effects are confirmed in the intervention group.

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What researchers measure

Primary outcomes

  1. Episodic memory

    Using the Huashan version of the Auditory Verbal Learning Test (AVLT) for assessment, it is mainly used to evaluate immediate recall, short-delay recall, long-delay recall, and other key components. The test includes 12 words belonging to three semantic categories (4 words per category). The testing procedure is as follows: The examiner reads out the 12 words in sequence, and the subject immediately recalls them. This process is repeated three consecutive times to form the immediate memory test. After an interval of 5 minutes, short-delay recall is conducted, and after 20 minutes, long-delay recall is implemented. The scoring rule is that each correctly recalled word earns 1 point. The immediate memory score is the sum of correct recalls from the first three trials (maximum score 36). This study records the scores for immediate recall, short-delay recall, and long-delay recall, with higher scores indicating better memory function.

    Time frame: week0,week12,week24

  2. Gobal cognitive function

    The assessment uses the Montreal Cognitive Assessment (MoCA). Higher scores indicate better performance, with a minimum score of 0 and a maximum score of 30.

    Time frame: week0,week12,week24

  3. Executive function

    The Shape Trail Test (STT) was used to assess executive function. The test consists of two parts: Part A requires participants to connect 25 numbers in ascending order; Part B involves 25 numbers presented within two different shapes. The scoring indicators are the time taken to complete STT-A and STT-B, with shorter completion times indicating better executive function.

    Time frame: week0,week12,week24

  4. Attention

    The Digit Symbol Substitution Test (DSST) is used to assess the patient's attention. The subject is required to match the corresponding symbols to the numbers (1-9) as quickly as possible within 90 seconds. Each correctly filled symbol earns 1 point, and a reversed symbol earns 0.5 points. The maximum score for the test is 90.

    Time frame: week0,week12,week24

  5. Linguistic function

    Animal verbal fluency is used to assess a patient's language fluency. The test requires the subject to name as many examples as possible within the category of animals in one minute. Scoring is typically based on the total number of correctly named animal names. Lower scores indicate reduced language ability.

    Time frame: week0,weel12,week24

Secondary outcomes

  1. Depression

    The short version of the Geriatric Depression Scale (Geriatric Depression Scale-15, GDS-15) is used for assessment. The total score ranges from 0 to 15, and the score is positively correlated with the severity of depression.

    Time frame: week0,weel12,week24

  2. Anxiety

    The Geriatric Anxiety Inventory-20 (GAI-20) is used for assessment. This scale consists of 20 items, and respondents answer based on their emotional feelings over the past week. A response of "Yes" is scored as 1 point, while "No" is scored as 0 points. The total score ranges from 0 to 20, with higher scores indicating more severe anxiety.

    Time frame: week0,week12,week24

  3. Social network

    The Lubben Social Network Scale-6 (LSNS-6) is a short version of the Lubben Social Network Scale. It is primarily used to measure an individual's level of social connectedness in two dimensions: family relationships and peer interactions. The scale consists of six assessment items and uses a graded scoring system: 0 points indicate no such social members, 1 point corresponds to 1 person, 2 points to 2 people, 3 points to 3-4 people, 4 points to 5-8 people, and 5 points applies to groups of 9 or more individuals. Lower scores indicate poorer levels of social network connectedness.

    Time frame: week0,week12,week24

  4. Social participation

    This study employed the Social Participation Level Assessment Tool revised by Wei Xiuping, which was developed based on national health survey data of the elderly population. The measurement tool comprises two main dimensions: cultural organization participation and family/personal affairs, encompassing a total of 10 specific items. A five-point Likert scale was used for measurement, and the total score is positively correlated with the level of social participation-that is, a higher score indicates a more significant degree of social participation among the respondents.

    Time frame: week0,week12,week24

  5. Timed "Up and Go" test

    During the test, the participant sits on a chair with armrests and a backrest. Upon hearing the instruction, they stand up, walk 3 meters forward at their usual gait, then turn around, return to the chair, and sit down. The average of two test trials is recorded.

    Time frame: week0,week12,week24

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Study locations

No study locations are listed for this record.

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References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07629531
Lead sponsor
China Medical University, China
Responsible party
Zhi Cai (Dr, China Medical University, China) — Principal investigator
First posted
Jun 5, 2026
Start date
Jun 30, 2026 (estimated)
Primary completion
Jun 30, 2029 (estimated)
Completion
Dec 1, 2029 (estimated)
Last update
Jun 5, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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