Mild Cognitive ImpairmentAllena-MenteNCT01793493
Cognitive Stimulation in Elderly Individuals at Risk to Develop Dementia (Allena-Mente).
A study testing Cognitive stimulation and Sanitary education in people with Mild Cognitive Impairment and Healthy Subjects With Family History for Dementia, run by Fondazione Golgi Cenci at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 70 to 75 years
- Conditions the study is for
- Mild Cognitive Impairment, Healthy Subjects With Family History for Dementia
- What is being tested?
- Cognitive stimulation and Sanitary education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2011to Jun 2015
- 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 70 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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).
Who cannot join
- (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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Cognitive Stimulation in Elderly Individuals at Risk to Develop Dementia: a Randomized Controlled Trial (Allena-Mente).
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).
Read the 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.
- Being tested
- Cognitive stimulation, Sanitary education
- Keywords
- Mild Cognitive Impairment, Cognitive Stimulation, Aging, Elderly, Randomized Controlled Trial
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive stimulationOther
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)
Sanitary educationOther
Participants attend two weekly meetings (for a total of 3 hours) focused on lifestyle education and brain functioning.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive stimulation | Experimental | Not described Receives: Other: Cognitive stimulation |
| Sanitary education | Active comparator | Not described Receives: Other: Sanitary education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term change from Baseline in Mini Mental State Examination (MMSE)
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.
Measured: baseline and up to 4 years
Secondary outcomes (4)
Change from Baseline in Mini Mental State Examination at 2-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.
Measured: baseline, two-weeks after the intervention
Change from Baseline in Montreal Cognitive Assessment (MoCA) at 2-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).
Measured: baseline, two-weeks after the intervention
Change from Baseline in Corsi test at 2-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
Measured: baseline, two-weeks after the intervention
Change from Baseline in Walking While Talking Dual Task at 2-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.
Measured: baseline, two-weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startMar 2011
- Primary completionMar 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Golgi Cenci
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer Federation Italy, Camillo Golgi Geriatric Institute, University of Pavia, Mario Negri Institute for Pharmacological Research
- Responsible party
- Principal investigator, Antonio Guaita, MD, Fondazione Golgi Cenci
- Investigators
- Antonio Guaita, MD, Study director, GolgiCenci Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793493
- Sponsor's protocol ID
- 02
- Acronym
- Allena-Mente
- Status last verified
- Sep 2023
- First submitted
- 13 Feb 2013
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25187003
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive Stimulation in Elderly Individuals at Risk to Develop Dementia: a Randomized Controlled Trial (Allena-Mente).
- ClinicalTrials.gov ID
- NCT01793493
- Acronym / sponsor ID
- Allena-Mente / 02
- Keywords
- Mild Cognitive Impairment, Cognitive Stimulation, Aging, Elderly, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Fondazione Golgi CenciUniversity, hospital or other
- Collaborators
- Alzheimer Federation Italy, Camillo Golgi Geriatric Institute, University of Pavia, Mario Negri Institute for Pharmacological Research
- Study start
- Mar 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 15 Feb 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.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive stimulation | Experimental | Other: Cognitive stimulation |
| Sanitary education | Active comparator | Other: Sanitary education |
Who may qualify
- Ages
- 70 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (8 listed)
- (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
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 |
|---|---|---|
| Cognitive stimulationParticipants 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) | Other | Cognitive stimulation |
| Sanitary educationParticipants attend two weekly meetings (for a total of 3 hours) focused on lifestyle education and brain functioning. | Other | Sanitary education |
Primary outcome
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.
4 secondary outcomes
Change from Baseline in Mini Mental State Examination at 2-weeks after the intervention
Time frame: baseline, two-weeks after the intervention
Change from Baseline in Montreal Cognitive Assessment (MoCA) at 2-weeks after the intervention
Time frame: baseline, two-weeks after the intervention
Change from Baseline in Corsi test at 2-weeks after the intervention
Time frame: baseline, two-weeks after the intervention
Change from Baseline in Walking While Talking Dual Task at 2-weeks after the intervention
Time frame: baseline, two-weeks after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Background: PubMed 25187003Polito 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.
- official web site of the organization responsible for the studyLink provided by the sponsor.
- official website of the caregivers organization, partner in the sponsorship of the researchLink provided by the sponsor.
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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.
Antonio Guaita, MD study director
GolgiCenci Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive stimulation and Sanitary education in people with Mild Cognitive Impairment and Healthy Subjects With Family History for Dementia, run by Fondazione Golgi Cenci at 1 site in Italy.
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 8 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: finished, as of the sponsor's last update on 13 Sep 2023. 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Long-term change from Baseline in Mini Mental State Examination (MMSE) (time frame: baseline and up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01793493, which also lists 1 linked publication.
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 13 Sep 2023.