NCT01793493

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

4 years

First QC Date

February 13, 2013

Last Update Submit

September 11, 2023

Conditions

Mild Cognitive ImpairmentHealthy Subjects With Family History for Dementia

Keywords

Mild Cognitive ImpairmentCognitive StimulationAgingElderlyRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline and up to 4 years

Secondary Outcomes (4)

  • Change from Baseline in Mini Mental State Examination at 2-weeks after the intervention

    baseline, two-weeks after the intervention

  • Change from Baseline in Montreal Cognitive Assessment (MoCA) at 2-weeks after the intervention

    baseline, two-weeks after the intervention

  • Change from Baseline in Corsi test at 2-weeks after the intervention

    baseline, two-weeks after the intervention

  • Change from Baseline in Walking While Talking Dual Task at 2-weeks after the intervention

    baseline, two-weeks after the intervention

Study Arms (2)

Cognitive stimulation

EXPERIMENTAL
Other: Cognitive stimulation

Sanitary education

ACTIVE COMPARATOR
Other: Sanitary education

Interventions

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)

Cognitive stimulation
Sanitary educationOTHER

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

Sanitary education

Eligibility Criteria

Age70 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Golgi Cenci Foundation

Abbiategrasso, Milan, 20081, Italy

Location

Related Publications (1)

  • 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.

    PMID: 25187003BACKGROUND

Related Links

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Antonio Guaita, MD

    GolgiCenci Foundation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 13, 2013

First Posted

February 15, 2013

Study Start

March 1, 2011

Primary Completion

March 1, 2015

Study Completion

June 1, 2015

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations

IT(1)