Mild Cognitive ImpairmentNCT01819623
Effect of Non-pharmacological Therapy on Cognitive Function of Patients With Cognitive Impairment
A study testing Non-pharmacological therapy in people with Mild Cognitive Impairment, run by National Institute of Medical Sciences and Nutrition, Salvador Zubiran at 1 site in Mexico.
Trial summary
Supervised nonpharmacologic therapy improve cognitive function in patients with Mild Cognitive Impairment Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Non-pharmacological therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- Start not givento Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 60 years and older with Mild Cognitive Impairment according to Petersen Criteria
- Phone number available
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
National Institue of Medical Sciences and Nutrition Salvador Zubirán
Mexico City, Mexico City, 14000
About this study
Supervised nonpharmacologic therapy improve cognitive function in patients with Mild Cognitive Impairment
- Conditions
- Mild Cognitive Impairment
- Being tested
- Non-pharmacological therapy
- Keywords
- Mild Cognitive Impairment, Cognitive training
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-pharmacological therapyOther
Also called Supervised nonpharmacologic 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
| Study group | Role | What they receive |
|---|---|---|
| Non-pharmacological therapy | Experimental | This group will be supervised nonpharmacologic therapy Receives: Other: Non-pharmacological therapy |
| Control | No intervention | This group will receive the standard treatment for mild cognitive impairment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
Cognitive function measured by Alzheimer's Disease Assessment Cognitive Scale (ADAS-Cog) sum of boxes after non-pharmacological intervention for six months.
Measured: six months
Secondary outcomes (2)
Cognitive function six months after completing intervention
Cognitive function measured by Alzheimer's Disease Assessment Cognitive Scale (ADAS-Cog) six months after completing intervention
Measured: one year
Depressive symptoms
Depressive symptoms measured by Geriatric Depression Scale (GDS) before and after intervention period
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Primary completionMar 2014 (estimated)
Why it stopped: Financial issues (no participants enrolled)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Medical Sciences and Nutrition, Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Alberto Ávila Funes, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
- Investigators
- JOSÉ ALBERTO MD ÁVILA, Geriatrician, Principal investigator, National Institute of Medical Sciences and Nutrition Salvador Zubirán
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819623
- Sponsor's protocol ID
- GER-830-13/14-1
- Status last verified
- Apr 2015
- First submitted
- 11 Mar 2013
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-pharmacological Therapy on Cognitive Function of Patients With Cognitive Impairment
- ClinicalTrials.gov ID
- NCT01819623
- Acronym / sponsor ID
- GER-830-13/14-1
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, Cognitive training
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Financial issues (no participants enrolled)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Medical Sciences and Nutrition, Salvador ZubiranUniversity, hospital or other
- Primary completion
- Mar 2014 (estimated)
- First posted
- 27 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Supervised nonpharmacologic therapy improve cognitive function in patients with Mild Cognitive Impairment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-pharmacological therapy | Experimental | Other: Non-pharmacological therapyThis group will be supervised nonpharmacologic therapy |
| Control | No intervention | –This group will receive the standard treatment for mild cognitive impairment |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 60 years and older with Mild Cognitive Impairment according to Petersen Criteria
- Phone number available
Key exclusion criteria (11 listed)
- Untreated depression
- Evidence of a reversible cause of cognitive decline
- Dementia of any type and stage
- Severe sensory deficit unresolved
- Metastatic cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-pharmacological therapyAlso: Supervised nonpharmacologic therapyIt 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 | Other | Non-pharmacological therapy |
Primary outcome
Cognitive function
Time frame: six months
Cognitive function measured by Alzheimer's Disease Assessment Cognitive Scale (ADAS-Cog) sum of boxes after non-pharmacological intervention for six months.
2 secondary outcomes
Cognitive function six months after completing intervention
Time frame: one year
Depressive symptoms
Time frame: six months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JOSÉ ALBERTO MD ÁVILA, Geriatrician principal investigator
National Institute of Medical Sciences and Nutrition Salvador Zubirán
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-pharmacological therapy in people with Mild Cognitive Impairment, run by National Institute of Medical Sciences and Nutrition, Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2015.