Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-01-03 @ 9:50 AM
Study NCT ID:
NCT01793493
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2013-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Stimulation in Elderly Individuals at Risk to Develop Dementia (Allena-Mente).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-11', 'studyFirstSubmitDate': '2013-02-13', 'studyFirstSubmitQcDate': '2013-02-14', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long-term change from Baseline in Mini Mental State Examination (MMSE)', 'timeFrame': 'baseline and up to 4 years', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Mini Mental State Examination at 2-weeks after the intervention', 'timeFrame': 'baseline, two-weeks after the intervention', 'description': 'MMSE is a brief test of mental status and cognitive function, commonly used in clinical research to screen global cognitive functioning.'}, {'measure': 'Change from Baseline in Montreal Cognitive Assessment (MoCA) at 2-weeks after the intervention', 'timeFrame': 'baseline, two-weeks after the intervention', 'description': '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).'}, {'measure': 'Change from Baseline in Corsi test at 2-weeks after the intervention', 'timeFrame': 'baseline, two-weeks after the intervention', 'description': 'Corsi test evaluates visual-spatial short-term memory. We used this test to implement non-verbal memory in our neuropsychological test battery'}, {'measure': 'Change from Baseline in Walking While Talking Dual Task at 2-weeks after the intervention', 'timeFrame': 'baseline, two-weeks after the intervention', 'description': '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.\n\nDual 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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mild Cognitive Impairment', 'Cognitive Stimulation', 'Aging', 'Elderly', 'Randomized Controlled Trial'], 'conditions': ['Mild Cognitive Impairment', 'Healthy Subjects With Family History for Dementia']}, 'referencesModule': {'references': [{'pmid': '25187003', 'type': 'BACKGROUND', 'citation': 'Polito L, Abbondanza S, Vaccaro R, Valle E, Davin A, Degrate A, Villani S, Guaita A. Cognitive stimulation in cognitively impaired individuals and cognitively healthy individuals with a family history of dementia: short-term results from the "Allena-Mente" randomized controlled trial. Int J Geriatr Psychiatry. 2015 Jun;30(6):631-8. doi: 10.1002/gps.4194. Epub 2014 Sep 3.'}], 'seeAlsoLinks': [{'url': 'http://www.golgicenci.it', 'label': 'official web site of the organization responsible for the study'}, {'url': 'http://www.alzheimer.it', 'label': 'official website of the caregivers organization, partner in the sponsorship of the research'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nSample 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.\n\nRandomization: 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).\n\nParticipants provided written informed consent before study participation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Positive diagnosis for mild cognitive impairment (MCI) according to Petersen's criteria;\n* 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).\n\nExclusion Criteria:\n\n* (Major physical illness) Compromission of motor performance of lower and upper limbs\n* Medical conditions leading to clinical instability;\n* Therapies that reduce cognitive and communicative abilities and consciousness;\n* Perceptual disorders (sight, hearing)\n* Language disorders\n* Education level lower than 3 years\n* Psychiatric and behavioral disorders\n* Addiction to drugs or alcohol"}, 'identificationModule': {'nctId': 'NCT01793493', 'acronym': 'Allena-Mente', 'briefTitle': 'Cognitive Stimulation in Elderly Individuals at Risk to Develop Dementia (Allena-Mente).', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Golgi Cenci'}, 'officialTitle': 'Effects of Cognitive Stimulation in Elderly Individuals at Risk to Develop Dementia: a Randomized Controlled Trial (Allena-Mente).', 'orgStudyIdInfo': {'id': '02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive stimulation', 'interventionNames': ['Other: Cognitive stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sanitary education', 'interventionNames': ['Other: Sanitary education']}], 'interventions': [{'name': 'Cognitive stimulation', 'type': 'OTHER', 'description': '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.\n\nMeetings (each lasting about 2 hours) have a common structure:\n\n* body awakening (10 minutes)\n* cognitive stimulation (1 hour and a half) scheduled as follow:\n\n * temporospatial orientation\n * attentional abilities\n * one of the following cognitive areas: language, executive functions, verbal and visual memory (encoding, consolidation, retrieval)', 'armGroupLabels': ['Cognitive stimulation']}, {'name': 'Sanitary education', 'type': 'OTHER', 'description': 'Participants attend two weekly meetings (for a total of 3 hours) focused on lifestyle education and brain functioning.', 'armGroupLabels': ['Sanitary education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20081', 'city': 'Abbiategrasso', 'state': 'Milan', 'country': 'Italy', 'facility': 'Golgi Cenci Foundation', 'geoPoint': {'lat': 45.39821, 'lon': 8.91678}}], 'overallOfficials': [{'name': 'Antonio Guaita, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GolgiCenci Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Golgi Cenci', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alzheimer Federation Italy', 'class': 'OTHER'}, {'name': 'Camillo Golgi Geriatric Institute', 'class': 'OTHER'}, {'name': 'University of Pavia', 'class': 'OTHER'}, {'name': 'Mario Negri Institute for Pharmacological Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Antonio Guaita, MD', 'investigatorAffiliation': 'Fondazione Golgi Cenci'}}}}