NCT01183806

Brief Summary

The purpose of this study is to determine whether a exercise program when combined with rivastigmine (Exelon patch) drug treatment compared with rivastigmine drug treatment alone would improve quality of life, ability to perform activities of daily living (ADL) and cognition in patients with Alzheimer's disease. Hypothesis: Ho: Rivastigmine drug treatment combined with exercise is not superior to rivastigmine drug treatment to improve quality of life of Alzheimer's disease patients. H1: Rivastigmine drug treatment combined with exercise is superior to rivastigmine drug treatment to improve quality of life of Alzheimer's disease patients, with an expectative of 15% of improvement in the quality of life scale measurement

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_3 alzheimer-disease

Timeline
Completed

Started Jul 2010

Shorter than P25 for phase_3 alzheimer-disease

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

July 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

March 20, 2012

Status Verified

March 1, 2012

Enrollment Period

1.5 years

First QC Date

August 16, 2010

Last Update Submit

March 19, 2012

Conditions

Alzheimer Disease

Keywords

Alzheimer's diseaseExerciseRivastigmineQuality of life

Outcome Measures

Primary Outcomes (1)

  • Patients' Quality of life

    Patients' Quality of life of assessed by Quality of life scale in Alzheimer's disease (QOL-AD)- Portuguese version

    Monthly for six months

Secondary Outcomes (4)

  • Cognition

    Monthly for six months

  • Caregivers' Quality of life

    Monthly for six months

  • Activities of daily living

    Monthly for six months

  • Functional mobility

    Monthly for six months

Study Arms (2)

Rivastigmine and exercise program

EXPERIMENTAL

Experimental group: Rivastigmine and exercise program: All patients will monthly receive Rivastigmine (Exelon patch). The exercise training program consists of two 40-minute sessions per week for six months and includes aerobic, strength, flexibility and balance training

Drug: RivastigmineOther: Exercise training program

Rivastigmine

ACTIVE COMPARATOR

Control group : Rivastigmine All patients will monthly receive Rivastigmine (Exelon patch)

Drug: Rivastigmine

Interventions

RivastigmineDRUG

All patients start on a 5-cm2 rivastigmine transdermal patch and their dose is progressively increased

Also known as: Rivastigmine use
RivastigmineRivastigmine and exercise program
Exercise training programOTHER

Exercise training program

Also known as: Rivastigmine use and exercise program
Rivastigmine and exercise program

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previous diagnosis of probable Alzheimer's disease
  • At least 55 years of age
  • Same caregiver (familiar or paid one) for at least 3 months before, who is able to follow the patient in a two-day/week exercise program
  • Do not be taking other prescribed medication for Alzheimer disease
  • Treated stable hypertension

You may not qualify if:

  • Mini-Mental State Examination (MMSE) score of less than 12
  • Can't follow simple commands;
  • Can't answer two or more items of Quality of life questionnaire
  • Practiced regular exercise or physiotherapy/ occupational therapy in the last two months.
  • Diagnosed psychiatric condition (including depression).
  • Use of neuroleptic drugs
  • Orthopedic, neurologic, or behavioral limitations that may preclude exercise training
  • Visual or hearing impairment that may preclude exercise training or comprehension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ferderal University of Bahia - DINEP

Salvador, Estado de Bahia, 40.110-170, Brazil

Location

Federal University of Bahia

Salvador, Estado de Bahia, 40110170, Brazil

Location

Related Publications (1)

  • Aguiar P, Monteiro L, Feres A, Gomes I, Melo A. Rivastigmine transdermal patch and physical exercises for Alzheimer's disease: a randomized clinical trial. Curr Alzheimer Res. 2014;11(6):532-7. doi: 10.2174/1567205011666140618102224.

    PMID: 24938502DERIVED

MeSH Terms

Conditions

Alzheimer DiseaseMotor Activity

Interventions

Rivastigmine

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

PhenylcarbamatesCarbamatesAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Paula Aguiar

    Federal University of Bahia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ailton de Souza Melo,PhD

Study Record Dates

First Submitted

August 16, 2010

First Posted

August 18, 2010

Study Start

July 1, 2010

Primary Completion

January 1, 2012

Study Completion

March 1, 2012

Last Updated

March 20, 2012

Record last verified: 2012-03

Locations

BR(2)