NCT01885806

Brief Summary

We aim to evaluate the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) for apathy treatment in patients with Alzheimer's disease (AD). We hypothesize that rTMS will be superior to placebo to reduce apathy symptoms and severity in patients with AD.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

2 active sites

Status
unknown

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

Study Start

First participant enrolled

June 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 25, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 25, 2013

Status Verified

June 1, 2013

Enrollment Period

1.5 years

First QC Date

June 18, 2013

Last Update Submit

June 24, 2013

Conditions

Alzheimer's DiseaseApathy

Keywords

Apathy; Alzheimer's disease; Cognition; Burden of Care

Outcome Measures

Primary Outcomes (1)

  • Change in apathy symptoms

    Reduction of 30% in the Apathy Inventoire scores between baseline and 12 weeks after treatment.

    12 weeks

Secondary Outcomes (2)

  • Change in ADAS-Cog scores

    12 weeks

  • Change in the Zarit Burden Scale

    12 weeks

Other Outcomes (1)

  • Safety assessment

    4th week, 8th week, 12th week

Study Arms (2)

Repetitive TMS

EXPERIMENTAL

Patients will receive 10 consecutive sessions of repetitive transcranial magnetic stimulation with the following protocol: Frequency: 10 Hz Intensity: 90% motor limiar Session duration: 16 minutes (20 sequencies of 6 seconds of stimulation followed by intervals of 30 seconds); Localization: Left pre-frontal dorsolateral cortex;

Device: Magnetic Stimulator Magstim Rapid 2

Sham TMS

SHAM COMPARATOR

Patients will receive 10 consecutive sessions of sham transcranial magnetic stimulation following the same protocol as the intervention arm, but with no magnetic stimulation of the brain.

Device: Sham Magnetic Stimulator

Interventions

Magnetic Stimulator Magstim Rapid 2DEVICE

All procedures will use the Magnetic Stimulator Magstim Rapid 2. Total of session: 10 rTMS protocol: Freqüency: 10 Hz Intensity: 90% limiar motor Session duration: 16 minutes (20 TMS sequences of 6 second with intervals of 30 seconds between each sequence) Location: Left dorsolateral pre-frontal cortex

Also known as: rTMS
Repetitive TMS
Sham Magnetic StimulatorDEVICE

This intervention will follow the same protocol of the rTMS except that subjects will not receive magnetic stimulation of the brain. Total of session: 10

Also known as: Sham
Sham TMS

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 60 to 85 years-old
  • Mild or moderate Alzheimer's disease (MMSE scores between 10 and 20)
  • Apathy diagnosis
  • On stable doses of cholinesterase inhibitors (donepezil, galantamine, rivastigmine) and/or memantine for at least 6 months prior to enrollment

You may not qualify if:

  • history of epilepsy or convulsions
  • History of migraine or headaches episodes twice per week or more
  • History of neurodegenerative diseases other than Alzheimer's disease
  • Current use of first generation antipsychotics, clozapine, tricyclic drugs or anticonvulsants
  • History of cerebral ischemic episode

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Federal University of Minas Gerais

Belo Horizonte, Outside of U.S., 30130-100, Brazil

RECRUITING

Federal University of Minas Gerais

Belo Horizonte, Outside of U.S., 30130-100, Brazil

RECRUITING

MeSH Terms

Conditions

Alzheimer DiseaseLethargy

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Breno S Diniz, MD, PhD

    Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Breno S Diniz, MD, PhD

CONTACT

+55 31 97950860brenosatler@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 18, 2013

First Posted

June 25, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

June 25, 2013

Record last verified: 2013-06

Locations

BR(2)