Clinical trial NCT04754152: Long-term Effect of θ Burst Magnetic Stimulation on Clinical Symptoms of Alzheimer Disease
Official title: Long-term Effect of θ Burst Magnetic Stimulation on Clinical Symptoms of Alzheimer Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Repetitive Transcranial Magnetic Stimulation
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 45
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a randomized, single-blind, parallel, placebo-controlled clinical trial assessing the efficacy of neuronavigational TBS among patients with AD. Fourty late-onset AD were included in the study, all the patients were divided into TBS groups and drug treatment group. Drug intervention group AD patients with drug regimen (donepezil 5mg / d) and primary care guidance, once every three months follow-up. TBS group is treated with TBS (a course of treatment every 3 months); after completing 4 treatments/follow-ups a year, evaluate the changes in MoCA, other clinical symptoms and multi-domain cognition tests, and brain Changes in structure and function.


Eligibility criteria: Inclusion Criteria:

* Subject diagnosed with early Alzheimer's disease or related diseases according to NINCDS-ACDRADA criteria.
* Subjects must have a MMSE score between 10 and 27,indicating mild cognitive impairment or dementia
* CDR score ≤ 2
* Subject under treatment by IAChE for at least 3 Weeks.
* psychotropic treatments are tolerated if they were administered and unchanged for at least 3 months

Exclusion Criteria:

* CDR \> 2
* Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder).

  - Page 5 of 6 \[DRAFT\] -
* History of head injury,stroke,or other neurologic disease.
* Organic brain defects on T1 or T2 images.
* History of seizures or unexplained loss of consciousness.
* Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator.
* Family history of medication refractory epilepsy.
* History of substance abuse within the last 6 months.

Primary outcomes:
measure: changes in Montreal Cognitive Assessment (MoCA)
timeFrame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
Secondary outcomes:
measure: The changes in MMSE(Mini Mental State Examination)
timeFrame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
measure: HAMD (Hamilton Depression Scale)
timeFrame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
measure: HAMA (Hamilton Anxiety Scale)
timeFrame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
measure: NPI (Neuropsychiatric Inventory)
timeFrame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
measure: ADL( Lawton-Brody Activities of Daily Living)
timeFrame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
measure: LMT (Logic Memory Test)
timeFrame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
measure: DST (Digital Span Test; Forward and Backward)
timeFrame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
measure: TMT (Trail Making Test)
timeFrame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
measure: JLOT(Judgment of line Judgment of line orientation test orientation test)
timeFrame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
measure: HVOT(Hooper visual organization test Hooper visual organization test)
timeFrame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
measure: The Stroop color test
timeFrame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
measure: MRI measures
timeFrame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
measure: Chinese version of the Auditory Verbal Learning Test (AVLT)
timeFrame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
measure: Verbal Fluency Test-letter and semantic (VFT-L/S).
timeFrame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
measure: Boston Naming Test (BNT)
timeFrame: baseline; week-2, moth-3, month-6, month-9 and 1-year follow-up
Other outcomes:
Locations:
city: Hefei
country: China
facility: Cognitive Neuropsychology Lab Anhui Medical University
state: Anhui
Study officials:
References: