NCT01819623

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 27, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

First QC Date

March 11, 2013

Last Update Submit

April 20, 2015

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive ImpairmentCognitive training

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Cognitive function six months after completing intervention

    one year

  • Depressive symptoms

    six months

Other Outcomes (1)

  • quality of life

    six months

Study Arms (2)

Non-pharmacological therapy

EXPERIMENTAL

This group will be supervised nonpharmacologic therapy

Other: Non-pharmacological therapy

Control

NO INTERVENTION

This group will receive the standard treatment for mild cognitive impairment

Interventions

Non-pharmacological therapyOTHER

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

Also known as: Supervised nonpharmacologic therapy
Non-pharmacological therapy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institue of Medical Sciences and Nutrition Salvador Zubirán

Mexico City, Mexico City, 14000, Mexico

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • JOSÉ ALBERTO MD ÁVILA, Geriatrician

    National Institute of Medical Sciences and Nutrition Salvador Zubirán

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 11, 2013

First Posted

March 27, 2013

Primary Completion

March 1, 2014

Last Updated

April 22, 2015

Record last verified: 2015-04

Locations

ME(1)