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

Not Applicable

Withdrawn

• Conditions: Mild Cognitive Impairment
• Interventions: Other: Non-pharmacological therapy

• Registration Number: NCT01819623
• Lead Sponsor: National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-11
• Study First Submitted QC: 2013-03-22
• Study First Posted: 2013-03-27
• Primary Completion: 2014-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-20
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-pharmacological therapy	Non-pharmacological therapy	This group will be supervised nonpharmacologic therapy

Primary Outcome Measures

Name	Time	Method
Cognitive function	six months	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

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

Trial Locations

Locations (1)

National Institue of Medical Sciences and Nutrition Salvador Zubirán; 🇲🇽 Mexico City, Mexico