NCT07692542

Brief Summary

Evaluate the safety and efficacy of personalized network-guided transcranial magnetic stimulation for treating behavioral and psychological symptoms in patients with Alzheimer's disease.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Jul 2026Feb 2027

Study Start

First participant enrolled

July 1, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

July 9, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 3, 2026

Last Update Submit

July 3, 2026

Conditions

Transcranial Magnetic StimulationIndividualized NavigationBehavioral and Psychological Symptoms in Alzheimer's Disease

Keywords

behavioral and psychological symptoms in Alzheimer's diseaseTranscranial Magnetic StimulationIndividualized navigation

Outcome Measures

Primary Outcomes (1)

  • Neuropsychiatric Inventory (NPI)

    The Neuropsychology Scale (NPI) evaluates 12 neuropsychiatric disorders which included 10 neuropsychiatric symptoms and 2 autonomic neurological symptoms based on the caregiver's perception of the patient's behavior and the perceived distress. Each item was evaluated for its occurrence frequency (1-4 points) and severity (1-3 points). The frequency and severity were multiplied to obtain the score (0-12 points) of each item.The patient's assessment rating ranges from 0 to 144, and the caregiver's distress rating score is 0 to 60. The lower the score, the lighter the symptoms.

    Baseline and 2 weeks

Secondary Outcomes (8)

  • Alzheimers Disease Assessment Scale Cognitive section (ADAS-Cog)

    Baseline and 2 weeks

  • Mini Mental State Examination (MMSE)

    Baseline and 2 weeks

  • Montreal Cognitive Assessment (MoCA)

    Baseline and 2 weeks

  • Digital Span Test; Forward and Backward (DST)

    Baseline and 2 weeks

  • Hamilton Depression Scale (HAMD)

    Baseline and 2 weeks

  • +3 more secondary outcomes

Study Arms (2)

BPSD real group

EXPERIMENTAL

Stimulation delivered by a real coil through MagStim Rapid2 and guided by BrainSight navigation system.

Other: transcranial magnetic stimulation

BPSD sham group

SHAM COMPARATOR

Stimulation delivered by a sham coil through MagStim Rapid2 and guided by BrainSight navigation system.

Other: transcranial magnetic stimulation

Interventions

transcranial magnetic stimulationOTHER

Neuronavigated Theta-Burst Transcranial Magnetic Stimulation Other Name:

BPSD real group

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Alzheimer's disease according to the 2011 NIA-AA diagnostic criteria. 2.Mini-Mental State Examination (MMSE) score between 10 and 24; 3.Clinical Dementia Rating (CDR) score between 0.5 and 2; 4.Neuropsychiatric Inventory (NPI) score ≥4; 5.Education duration ≥5 years, or ability to complete the required cognitive and neuropsychological assessments; 6.Age ≥50 years and right-handedness; 7.Stable use of anti-dementia medications, including an NMDA receptor antagonist and/or cholinesterase inhibitors, for at least one month before rTMS intervention; 8.The patient and his or her family member or legal representative are able to understand the study procedures and provide written informed consent.

You may not qualify if:

  • \. Recevied rTMS treatment in the past 3 months. 2. Depression or other psychiatric disorders. 3. History of head injury, stroke, epilepsy or other neurologic disease. 4. Organic brain defects on T1 or T2 images. 5. History of unexplained loss of consciousness. 6. Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, or any implanted medical device that is incompatible with MRI. 7. Family history of medication refractory epilepsy. 8. History of substance abuse within the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anhui Medical University

Hefei, Anhui, 230000, China

Location

MeSH Terms

Conditions

Behavior

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Central Study Contacts

Kai Wang

CONTACT

+86-0551-62922263wangkai1964@126.com

Xingqi Wu

CONTACT

+86 18134516380wuxingqi09@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of medical psychological department, Anhui Medical University

Study Record Dates

First Submitted

July 3, 2026

First Posted

July 9, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

July 9, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)