Mild Cognitive Impairment (MCI)Silver Agri AgNCT06754202
Silver Agri Age: Longevity, Intrinsic Capacity and Cognitive Impairment Into Farmlands and Natural Environments: Updating Contexts Following the "Montessori" Action
A study testing Social activities with cognitive stimulation in people with Mild Cognitive Impairment (MCI), run by Istituto Nazionale di Ricovero e Cura per Anziani at 2 sites in Italy.
Trial summary
This project aims to enhance the intrinsic capacities of elderly individuals with mild cognitive impairment by promoting innovative activities based on the Montessori approach within the context of agricultural multifunctionality. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- Social activities with cognitive stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesItaly
- Study dates
- 3 May 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of mild cognitive impairment (MCI);
- Mini Mental State Examination ≥ 24;
- ability and willingness to sign informed consent
Who cannot join
- Mini Mental State Examination < 24;
- severe visual impairment;
- inability to walk without help or assistance, Tinetti's scale <20
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
INRCA Hospital
Ancona, 60127
Anna Rita Bonfigli, 0718003719
Cristina Gagliardi, MsC
- Recruiting
INRCA Hospital
Fermo, 63900
Anna Rita Bonfigli, 0718003719
Cinzia Giuli, Psych
About this study
This project aims to enhance the intrinsic capacities of elderly individuals with mild cognitive impairment by promoting innovative activities based on the Montessori approach within the context of agricultural multifunctionality.
By selecting a rural environment with educational characteristics, we aim to involve individuals with mild cognitive deficits and their families in a personalized therapeutic journey. Through various activities, including horticulture, pet therapy, occupational therapies, sensory and food laboratories, we stimulate cognitive and motor skills, promoting a healthy and balanced lifestyle
Read the detailed description
Promoting innovative activities following the "Montessori" action in the context of the agricultural multifunctionality, in order to leverage the intrinsic capacity in older people with cognitive impairment.
- Identifying a rural environment with educational features.
- Identifying individuals with mild cognitive impairments and relations with their families.
- Outlining individual therapeutic goals for each participant through different activities: horticulture, pet therapy, occupational therapies, sensory laboratories, functional food laboratories for a healthy and balanced diet suitable for the first symptoms of dementia, physical activity and continuous social activity between different generations.
- Horticulture, pet therapy, occupational therapy, sensory labs, physical activity, and social activities IN CONTINUITY between different generations.
- Spreading the results to a wide National and International audience.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- Social activities with cognitive stimulation
- Keywords
- older people, mild cognitive impairment, social farming, montessori approach
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social activities with cognitive stimulationOther
The nine-month program will include social activities following the "Montessori" action in the context of the agricultural multifunctionality such as horticulture, pet therapy, occupational therapy, sensory labs, physical activity held three days a week for five hours each day.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with mild cognitive impairment (MCI) | Experimental | Subjects with mild cognitive oimpairment (MCI) and self-sufficient in mobility that agreed to partecipate in various activities in rural enviroment. Receives: Other: Social activities with cognitive stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the positive and negative affects
The PANAS (Positive and Negative Affect Schedule) produces two distinct dimensions of affect: Positive Affect (PA): Measures emotions like joy, interest, excitement, and enthusiasm and Negative Affect (NA): Measures emotions like fear, anger, sadness, and guilt. Participants rate each of the 20 items (10 for PA, 10 for NA) on a 5-point scale (from 1 = "Very slightly or not at all" to 5 = "Extremely"). The possible score range for both PA and NA is 10 to 50.
Higher scores indicate higher levels of that particular affect Scores for each subscale are calculated by summing the ratings for the corresponding items.
Measured: At baseline and after 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start3 May 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
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 Impairment (MCI)Studies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- pre-post study
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Collaborators
- Regione Marche
- Responsible party
- Sponsor
- Investigators
- Cristina Gagliardi, MsC, Study chair, IRCCS INRCA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754202
- Sponsor's protocol ID
- INRCA_005_2024
- Acronym
- Silver Agri Ag
- Status last verified
- Dec 2024
- First submitted
- 23 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gambella E, Lombardi L, Cicconi D, Raccichini A, Paciaroni L, Giuli C, Bonfigli AR, Fabbietti P, Pelliccioni G, Gagliardi C. The Silver Agri Age project in Italy: a Montessori-inspired social intervention with older adults with mild cognitive impairment. Single-group pre-post pilot study protocol. Front Public Health. 2025 May 16;13:1561263. doi: 10.3389/fpubh.2025.1561263. eCollection 2025.
PubMed 40453497
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silver Agri Age: Longevity, Intrinsic Capacity and Cognitive Impairment Into Farmlands and Natural Environments: Updating Contexts Following the "Montessori" Action
- ClinicalTrials.gov ID
- NCT06754202
- Acronym / sponsor ID
- Silver Agri Ag / INRCA_005_2024
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- older people, mild cognitive impairment, social farming, montessori approach
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Collaborators
- Regione Marche
- Study start
- 3 May 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 31 Dec 2024 (actual)
- 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.
This project aims to enhance the intrinsic capacities of elderly individuals with mild cognitive impairment by promoting innovative activities based on the Montessori approach within the context of agricultural multifunctionality.
By selecting a rural environment with educational characteristics, we aim to involve individuals with mild cognitive deficits and their families in a personalized therapeutic journey. Through various activities, including horticulture, pet therapy, occupational therapies, sensory and food laboratories, we stimulate cognitive and motor skills, promoting a healthy and balanced lifestyle
Detailed description
Promoting innovative activities following the "Montessori" action in the context of the agricultural multifunctionality, in order to leverage the intrinsic capacity in older people with cognitive impairment.
- Identifying a rural environment with educational features.
- Identifying individuals with mild cognitive impairments and relations with their families.
- Outlining individual therapeutic goals for each participant through different activities: horticulture, pet therapy, occupational therapies, sensory laboratories, functional food laboratories for a healthy and balanced diet suitable for the first symptoms of dementia, physical activity and continuous social activity between different generations.
- Horticulture, pet therapy, occupational therapy, sensory labs, physical activity, and social activities IN CONTINUITY between different generations.
- Spreading the results to a wide National and International audience.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pre-post study
| Arm | Type | Receives |
|---|---|---|
| Subjects with mild cognitive impairment (MCI) | Experimental | Other: Social activities with cognitive stimulationSubjects with mild cognitive oimpairment (MCI) and self-sufficient in mobility that agreed to partecipate in various activities in rural enviroment. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of mild cognitive impairment (MCI);
- Mini Mental State Examination ≥ 24;
- ability and willingness to sign informed consent
Key exclusion criteria (3 listed)
- Mini Mental State Examination < 24;
- severe visual impairment;
- inability to walk without help or assistance, Tinetti's scale <20
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 |
|---|---|---|
| Social activities with cognitive stimulationThe nine-month program will include social activities following the "Montessori" action in the context of the agricultural multifunctionality such as horticulture, pet therapy, occupational therapy, sensory labs, physical activity held three days a week for five hours each day. | Other | Subjects with mild cognitive impairment (MCI) |
Primary outcome
Changes in the positive and negative affects
Time frame: At baseline and after 9 months
The PANAS (Positive and Negative Affect Schedule) produces two distinct dimensions of affect: Positive Affect (PA): Measures emotions like joy, interest, excitement, and enthusiasm and Negative Affect (NA): Measures emotions like fear, anger, sadness, and guilt. Participants rate each of the 20 items (10 for PA, 10 for NA) on a 5-point scale (from 1 = "Very slightly or not at all" to 5 = "Extremely"). The possible score range for both PA and NA is 10 to 50. Higher scores indicate higher levels of that particular affect Scores for each subscale are calculated by summing the ratings for the corresponding items.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Derived from this study: PubMed 40453497Gambella E, Lombardi L, Cicconi D, Raccichini A, Paciaroni L, Giuli C, Bonfigli AR, Fabbietti P, Pelliccioni G, Gagliardi C. The Silver Agri Age project in Italy: a Montessori-inspired social intervention with older adults with mild cognitive impairment. Single-group pre-post pilot study protocol. Front Public Health. 2025 May 16;13:1561263. doi: 10.3389/fpubh.2025.1561263. eCollection 2025.
Related trials for Mild Cognitive Impairment (MCI)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
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.
Cristina Gagliardi, MsC study chair
IRCCS INRCA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social activities with cognitive stimulation in people with Mild Cognitive Impairment (MCI), run by Istituto Nazionale di Ricovero e Cura per Anziani at 2 sites 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Rita Bonfigli, PhD (00390718003719, a.bonfigli@inrca.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the positive and negative affects (time frame: At baseline and after 9 months). 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 NCT06754202, 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 31 Dec 2024.