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Non-Pharmacological InterventionsNCT07629531

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

A study testing non-pharmacological interventions and Waiting List in people with Non-Pharmacological Interventions, run by China Medical University, China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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 more about this study

Who is it for?
Ages 60 to 85 years
Conditions the study is for
Non-Pharmacological Interventions
What is being tested?
non-pharmacological interventions and Waiting List
Could I receive a placebo?
No, everyone receives an active treatment
How many people
218 participants
Where
No sites listed yet
Study dates
30 Jun 2026to 1 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria Aged ≥60 Community dwelling Subjective memory decline, confirmed by Subjective Cognitive Decline Questionnaire(SCD-Q9)≥5 Montreal Cognitive Assessment (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 informed consent 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 contraindications Those currently participating in other research trials.

About this study

Official title: Applied Research on a Group-based Non-pharmacological Intervention Program for Community-dwelling Older Adults With Subjective Cognitive Decline

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.

Being tested
non-pharmacological interventions, Waiting List

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • non-pharmacological interventionsOther

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

  • Waiting ListOther

    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.

Study groups in NCT07629531
Study groupRoleWhat they receive
Non-Pharmacological InterventionsExperimentalNon-Pharmacological Interventions
Receives: Other: non-pharmacological interventions
Waiting List Control GroupOtherTo 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.
Receives: Other: Waiting List

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: week0，weel12，week24

Secondary outcomes (5)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: week0，week12，week24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2026
  2. Study start30 Jun 2026 (estimated)
  3. Primary completion30 Jun 2029 (estimated)
  4. Study completion1 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
218 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07629531
Sponsor's protocol ID
【2026】161
Status last verified
Jun 2026
First submitted
20 May 2026
Last updated
5 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing non-pharmacological interventions and Waiting List in people with Non-Pharmacological Interventions, run by China Medical University, China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Episodic memory (time frame: week0，week12，week24). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07629531.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.

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