NCT03612622

Brief Summary

To investigate the treatment effect of theta-burst transcranial magnetic stimulation on Alzheimer patients, and the underlying neural mechanism by MRI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

August 14, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

2.4 years

First QC Date

July 5, 2018

Last Update Submit

January 30, 2021

Conditions

Magnetic Resonance ImagingAlzheimer DiseaseTranscranial Magnetic Stimulation

Keywords

Transcranial Magnetic StimulationMagnetic Resonance ImagingAlzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • Associative Memory

    The changes in Associative Memory will constitute the major research outcome measure used to assess response to rTMS.

    baseline, 2 weeks and 8 weeks after treatment

Secondary Outcomes (14)

  • The changes in MMSE(Mini Mental State Examination)

    baseline, 2 weeks and 8 weeks after treatment

  • LMT (Logic Memory Test)

    baseline, 2 weeks and 8 weeks after treatment

  • DST (Digital Span Test; Forward and Backward)

    baseline, 2 weeks and 8 weeks after treatment

  • TMT (Trail Making Test)

    baseline, 2 weeks and 8 weeks after treatment

  • HAMD (Hamilton Depression Scale)

    baseline, 2 weeks and 8 weeks after treatment

  • +9 more secondary outcomes

Study Arms (2)

Transcranial Magnetic Stimulation-Real

ACTIVE COMPARATOR

Participants will receive active TMS once daily for two weeks

Other: transcranial magnetic stimulation

Transcranial Magnetic Stimulation-Sham

PLACEBO COMPARATOR

Participants will receive sham TMS once daily for two weeks

Other: transcranial magnetic stimulation

Interventions

transcranial magnetic stimulationOTHER

Intermittent Theta-Burst Transcranial Magnetic Stimulation

Transcranial Magnetic Stimulation-RealTranscranial Magnetic Stimulation-Sham

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 months.
  • psychotropic treatments are tolerated if they were administered and unchanged for at least 3 months

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anhui Medical University

Hefei, Anhui, 230032, China

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, 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 5, 2018

First Posted

August 2, 2018

Study Start

August 14, 2018

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

February 2, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)