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Cognitive Stimulation in Elderly Individuals at Risk to Develop Dementia (Allena-Mente). (Allena-Mente)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01793493
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : August 17, 2015
Sponsor:
Collaborators:
Alzheimer Federation Italy
Camillo Golgi Geriatric Institute
University of Pavia
Mario Negri Institute for Pharmacological Research
Information provided by (Responsible Party):
Fondazione Golgi Cenci

Brief Summary:
The Allena-Mente study is a randomized, controlled, single-blind trial assessing the efficacy of cognitive stimulation (CS) compared to an active control group, participating to sanitary education lessons (AC). This non-pharmacological intervention is delivered to Mild Cognitive Impairment (MCI) and cognitively healthy individuals with first-degree relative with dementia (NDFAM).

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Healthy Subjects With Family History for Dementia Other: Cognitive stimulation Other: Sanitary education Phase 2

Detailed Description:

The experimental protocol was set up with a pilot study on healthy elderly individuals. Data from this pilot study will be excluded from the statistical analysis.

Sample size: a priori power analysis was performed to evaluate the sample size required for the study. MCI and NDFAM were considered separately for sample size calculation. For power calculation a two-tailed test was used and a significance level (α) and test power (1-β) were set at 0.05 and 0.8/0.9, respectively.

Randomization: The individuals belonging to MCI and NDFAM subgroup were randomly assigned to CS or AC group. The randomization was performed by a statistician blind to participants characteristics using the Random Allocation Software. Allocation ratio was set at 1:1, stratification was performed for birth cohort (≤1937 and ≥1938), education level (years of education ≤5 years and >5 years).

Participants provided written informed consent before study participation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Cognitive Stimulation in Elderly Individuals at Risk to Develop Dementia: a Randomized Controlled Trial (Allena-Mente).
Study Start Date : March 2011
Actual Primary Completion Date : March 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: Cognitive stimulation Other: Cognitive stimulation

Participants are pooled in small groups (6-8 individuals). Each group participates to ten twice weekly meetings. Each CS session is run by one trained operator. One observer participates to the sessions to guarantee homogeneity between different operators. Exercises are structured with an increasing cognitive complexity and are tailored to the characteristics of the group.

Meetings (each lasting about 2 hours) have a common structure:

  • body awakening (10 minutes)
  • cognitive stimulation (1 hour and a half) scheduled as follow:

    • temporospatial orientation
    • attentional abilities
    • one of the following cognitive areas: language, executive functions, verbal and visual memory (encoding, consolidation, retrieval)

Active Comparator: Sanitary education Other: Sanitary education
Participants attend two weekly meetings (for a total of 3 hours) focused on lifestyle education and brain functioning.




Primary Outcome Measures :
  1. Long-term change from Baseline in Mini Mental State Examination (MMSE) [ Time Frame: baseline and up to 4 years ]
    Mini Mental State examination (MMSE) is a brief test of mental status and cognitive function, commonly used in clinical research to screen global cognitive functioning.


Secondary Outcome Measures :
  1. Change from Baseline in Mini Mental State Examination at 2-weeks after the intervention [ Time Frame: baseline, two-weeks after the intervention ]
    MMSE is a brief test of mental status and cognitive function, commonly used in clinical research to screen global cognitive functioning.

  2. Change from Baseline in Montreal Cognitive Assessment (MoCA) at 2-weeks after the intervention [ Time Frame: baseline, two-weeks after the intervention ]
    MoCA is a brief cognitive screening tool with a high sensitivity and specificity for detecting MCI in individuals performing in the normal range on the MMSE (avoiding ceiling effect).

  3. Change from Baseline in Corsi test at 2-weeks after the intervention [ Time Frame: baseline, two-weeks after the intervention ]
    Corsi test evaluates visual-spatial short-term memory. We used this test to implement non-verbal memory in our neuropsychological test battery

  4. Change from Baseline in Walking While Talking Dual Task at 2-weeks after the intervention [ Time Frame: baseline, two-weeks after the intervention ]

    Walking speed measures the ability to perform a dual action task. Single task: participants walk back and forth along an indicated distance of 5 meters with no pausing.

    Dual task: participants perform the same movement as in the single task while listing personal names in a loud voice (female names for men and male names for women) The span between time needed to perform the dual and the single task is registered.




Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years to 75 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive diagnosis for mild cognitive impairment (MCI) according to Petersen's criteria;
  • Cognitively healthy elderly individuals, having at least one first-degree relative affected by dementia (Alzheimer's Disease, pre-senile and senile dementia, vascular dementia) (NDFAM).

Exclusion Criteria:

  • (Major physical illness) Compromission of motor performance of lower and upper limbs
  • Medical conditions leading to clinical instability;
  • Therapies that reduce cognitive and communicative abilities and consciousness;
  • Perceptual disorders (sight, hearing)
  • Language disorders
  • Education level lower than 3 years
  • Psychiatric and behavioral disorders
  • Addiction to drugs or alcohol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793493


Locations
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Italy
Golgi Cenci Foundation
Abbiategrasso, Milan, Italy, 20081
Sponsors and Collaborators
Fondazione Golgi Cenci
Alzheimer Federation Italy
Camillo Golgi Geriatric Institute
University of Pavia
Mario Negri Institute for Pharmacological Research
Investigators
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Study Director: Antonio Guaita, MD GolgiCenci Foundation

Additional Information:
Publications:
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Responsible Party: Fondazione Golgi Cenci
ClinicalTrials.gov Identifier: NCT01793493    
Other Study ID Numbers: 02
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: August 17, 2015
Last Verified: August 2015
Keywords provided by Fondazione Golgi Cenci:
Mild Cognitive Impairment
Cognitive Stimulation
Aging
Elderly
Randomized Controlled Trial
Additional relevant MeSH terms:
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Dementia
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders