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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02908815




Registration number
NCT02908815
Ethics application status
Date submitted
13/09/2016
Date registered
21/09/2016

Titles & IDs
Public title
Investigating the Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) as a Treatment for Alzheimer's Disease
Scientific title
Investigating the Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) as a Treatment for Alzheimer's Disease
Secondary ID [1] 0 0
B2016:077
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - rTMS active treatment
Treatment: Devices - rTMS sham treatment

Experimental: 4 weeks active treatment - 4 weeks of rTMS active treatment applied using an active rTMS coil.

Experimental: 2 weeks active treatment - 2 weeks of rTMS active treatment applied using an active rTMS coil.

Sham comparator: 4 weeks sham treatment - 4 weeks of rTMS sham treatment applied using a modified rTMS coil which does not stimulate the brain.

Sham comparator: 2 weeks sham treatment - 2 weeks of rTMS sham treatment applied using a modified rTMS coil which does not stimulate the brain.


Treatment: Devices: rTMS active treatment
Repetitive Transcranial Magnetic Stimulation uses magnetic pulses to active neurons.

Treatment: Devices: rTMS sham treatment
A fake treatment designed to mimic the sensations of rTMS
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) change
Timepoint [1] 0 0
Weeks 0 and 5
Secondary outcome [1] 0 0
Stroop Test
Timepoint [1] 0 0
Weeks 0, 3, 5, 11, 19, and 27 for the 2 week group and weeks 0, 3, 5, 13, 21, and 29 for the 4 week groups
Secondary outcome [2] 0 0
Digit Span Test
Timepoint [2] 0 0
Weeks 0, 3, 5, 11, 19, and 27 for the 2 week group and weeks 0, 3, 5, 13, 21, and 29 for the 4 week groups
Secondary outcome [3] 0 0
Verbal Fluency Test (VFT)
Timepoint [3] 0 0
Weeks 0, 3, 5, 11, 19, and 27 for the 2 week group and weeks 0, 3, 5, 13, 21, and 29 for the 4 week groups
Secondary outcome [4] 0 0
Neuropsychiatric Inventory-Questionnaire (NPI-Q)
Timepoint [4] 0 0
Weeks 0, 3, 5, 11, 19, and 27 for the 2 week group and weeks 0, 3, 5, 13, 21, and 29 for the 4 week groups
Secondary outcome [5] 0 0
Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
Timepoint [5] 0 0
Weeks 0, 3, 5, 11, 19, and 27 for the 2 week group and weeks 0, 3, 5, 13, 21, and 29 for the 4 week groups
Secondary outcome [6] 0 0
Zarit Burden Interview (ZBI)
Timepoint [6] 0 0
Weeks 0, 3, 5, 11, 19, and 27 for the 2 week group and weeks 0, 3, 5, 13, 21, and 29 for the 4 week groups
Secondary outcome [7] 0 0
Treatment Satisfaction Questionnaire for Medication (TSQM)
Timepoint [7] 0 0
Weeks 3, 5, 11, 19, and 27 for the 2 week group and weeks 0, 3, 5, 13, 21, and 29 for the 4 week groups
Secondary outcome [8] 0 0
Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) effect over time
Timepoint [8] 0 0
Weeks 0, 3, 11, 19, and 27 for the 2 week group and weeks 0, 3, 13, 21, and 29 for the 4 week groups
Secondary outcome [9] 0 0
Semantic Fluency Test (SFT)
Timepoint [9] 0 0
Before and immediately after rTMS intervention in Week 1, at weeks 5 and 11 for the 2 week group and before and immediately after rTMS intervention in Week 1, at weeks 5, and 13 for the 4 week groups
Secondary outcome [10] 0 0
Clinical Dementia Rating (CDR) sum of boxes
Timepoint [10] 0 0
Week 27 for the 2 week group and week 29 for the 4 week group

Eligibility
Key inclusion criteria
Inclusion criteria:

* Individuals must have a MoCA score between 7 and 25, indicating mild cognitive impairment or dementia, a CDR score of 1-2, and a CSDD score of 18 or less.
* Participants must have probable early or moderate Alzheimer's disease as confirmed by their treating neurologist, geriatrician, or psychiatrist, and/or by the study doctors.
* Participants must be +55 years old.
* Participants must be taking a stable dose of an acetylcholinesterase inhibitor for at least 3 months prior to study entry with no plans to change medication for the duration of the study. Or if participants decide to stop taking their Alzheimer's disease related medication, they must wait a minimum of 6 weeks prior to the start of the intervention.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Psychiatric conditions/disorders, or current neurological or medical disorders, other than AD, that could interfere with the subjects' cooperative participation (e.g. Severe agitation, prominent anxiety)
* Mental retardation
* Impaired visual and auditory acuity that confounds performance in cognitive tests
* Being diagnosed explicitly by other forms of dementia
* Confounding psychiatric disorders (e.g., schizophrenia, bipolar affective disorder) or current neurological, systemic, or medical disorders (e.g., liver disease, congestive heart failure, severe COPD) that may impair cognition and/or could affect attention span.
* Use of benzodiazepines or other hypnotics during the study and preceding two weeks
* Use of drugs with anticholinergic properties
* Pharmacological immunosuppression
* Participation in a clinical trial with any investigational agent within two weeks prior to study enrollment
* Current alcohol abuse
* History of epileptic seizures or epilepsy
* Contraindication for receiving TMS treatment according to a TMS questionnaire.
* Clinically significant abnormal laboratory findings which have not been approved by the Principal Investigator.
* Inability to adequately communicate in English in Manitoba and Australia sites and either English or French in Montreal site.
* Previous treatment with rTMS within the past 3 months
* A change in medication for AD, mood disorders, or pain during the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2022
Sample size
Target
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash University - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Manitoba
Country [2] 0 0
Canada
State/province [2] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Other
Name
University of Manitoba
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Zahra Moussavi, PhD
Address 0 0
Department of Biomedical Engineering, University of Manitoba
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Zahra Moussavi, PhD
Address 0 0
Country 0 0
Phone 0 0
204-474-7023
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data will be shared with two other institutes: McGill and Monash Universities, who are part of the same team.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
2016-12-01 till 2021-12-30
Available to whom?
Data are shared over a database that is only accessible by the sites of the study.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02908815