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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01819623
• Other study ID #: GER-830-13/14-1
• Status: Withdrawn
• Phase: N/A
• First received: March 11, 2013
• Last updated: April 20, 2015

Study information

• Verified date: April 2015
• Source: National Institute of Medical Sciences and Nutrition, Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Other:
• Non-pharmacological therapy
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

Locations

Country	Name	City	State
Mexico	National Institue of Medical Sciences and Nutrition Salvador Zubirán	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	quality of life	Quality of life measured by a scale validated in Spanish before and after intervention period	six months	No
Primary	Cognitive function	Cognitive function measured by Alzheimer's Disease Assessment Cognitive Scale (ADAS-Cog) sum of boxes after non-pharmacological intervention for six months.	six months	No
Secondary	Cognitive function six months after completing intervention	Cognitive function measured by Alzheimer's Disease Assessment Cognitive Scale (ADAS-Cog) six months after completing intervention	one year	No
Secondary	Depressive symptoms	Depressive symptoms measured by Geriatric Depression Scale (GDS) before and after intervention period	six months	No