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Effect of Non-pharmacological Therapy on Cognitive Function of Patients With Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status
Withdrawn
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Non-pharmacological therapy
Sponsored by
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, Cognitive training

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients 60 years and older with Mild Cognitive Impairment according to Petersen Criteria
  • Phone number available

Exclusion Criteria:

  • Untreated depression
  • Evidence of a reversible cause of cognitive decline
  • Dementia of any type and stage
  • Severe sensory deficit unresolved
  • Metastatic cancer
  • Hemoglobin level < 8g/dL
  • Chronic Obstructive Pulmonary Disease Gold stage 3 or 4
  • Congestive Heart Failure decompensated, unstable angina o Functional Class IV according to New York Heart Association
  • Participation in another protocol that prevents its participation in this research
  • Chronic use of benzodiazepines, tricyclic antidepressants
  • Patients whose place of residence can not attend the sessions

Sites / Locations

  • National Institue of Medical Sciences and Nutrition Salvador Zubirán

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Non-pharmacological therapy

Control

Arm Description

This group will be supervised nonpharmacologic therapy

This group will receive the standard treatment for mild cognitive impairment

Outcomes

Primary Outcome Measures

Cognitive function
Cognitive function measured by Alzheimer's Disease Assessment Cognitive Scale (ADAS-Cog) sum of boxes after non-pharmacological intervention for six months.

Secondary Outcome Measures

Cognitive function six months after completing intervention
Cognitive function measured by Alzheimer's Disease Assessment Cognitive Scale (ADAS-Cog) six months after completing intervention
Depressive symptoms
Depressive symptoms measured by Geriatric Depression Scale (GDS) before and after intervention period

Full Information

First Posted
March 11, 2013
Last Updated
April 20, 2015
Sponsor
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
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1. Study Identification

Unique Protocol Identification Number
NCT01819623
Brief Title
Effect of Non-pharmacological Therapy on Cognitive Function of Patients With Cognitive Impairment
Official Title
Effect of Non-pharmacological Therapy on Cognitive Function of Patients With Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Financial issues (no participants enrolled)
Study Start Date
undefined (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Medical Sciences and Nutrition, Salvador Zubiran

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Supervised nonpharmacologic therapy improve cognitive function in patients with Mild Cognitive Impairment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mild Cognitive Impairment, Cognitive training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-pharmacological therapy
Arm Type
Experimental
Arm Description
This group will be supervised nonpharmacologic therapy
Arm Title
Control
Arm Type
No Intervention
Arm Description
This group will receive the standard treatment for mild cognitive impairment
Intervention Type
Other
Intervention Name(s)
Non-pharmacological therapy
Other Intervention Name(s)
Supervised nonpharmacologic therapy
Intervention Description
It consists of a weekly two-hour session. During the first hour yoga classes will taught by teacher, during second hour supervised cognitive training by a psychologist based on Memory Program designed by Memory Unit of Madrid
Primary Outcome Measure Information:
Title
Cognitive function
Description
Cognitive function measured by Alzheimer's Disease Assessment Cognitive Scale (ADAS-Cog) sum of boxes after non-pharmacological intervention for six months.
Time Frame
six months
Secondary Outcome Measure Information:
Title
Cognitive function six months after completing intervention
Description
Cognitive function measured by Alzheimer's Disease Assessment Cognitive Scale (ADAS-Cog) six months after completing intervention
Time Frame
one year
Title
Depressive symptoms
Description
Depressive symptoms measured by Geriatric Depression Scale (GDS) before and after intervention period
Time Frame
six months
Other Pre-specified Outcome Measures:
Title
quality of life
Description
Quality of life measured by a scale validated in Spanish before and after intervention period
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients 60 years and older with Mild Cognitive Impairment according to Petersen Criteria Phone number available Exclusion Criteria: Untreated depression Evidence of a reversible cause of cognitive decline Dementia of any type and stage Severe sensory deficit unresolved Metastatic cancer Hemoglobin level < 8g/dL Chronic Obstructive Pulmonary Disease Gold stage 3 or 4 Congestive Heart Failure decompensated, unstable angina o Functional Class IV according to New York Heart Association Participation in another protocol that prevents its participation in this research Chronic use of benzodiazepines, tricyclic antidepressants Patients whose place of residence can not attend the sessions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JOSÉ ALBERTO MD ÁVILA, Geriatrician
Organizational Affiliation
National Institute of Medical Sciences and Nutrition Salvador Zubirán
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institue of Medical Sciences and Nutrition Salvador Zubirán
City
Mexico City
ZIP/Postal Code
14000
Country
Mexico

12. IPD Sharing Statement

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Effect of Non-pharmacological Therapy on Cognitive Function of Patients With Cognitive Impairment

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