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

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).

Conditions

• Mild Cognitive Impairment
• Healthy Subjects With Family History for Dementia

Interventions

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)

OTHER

Sanitary education

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

Sponsors & Collaborators

• Alzheimer Federation Italy

  collaborator OTHER

• Camillo Golgi Geriatric Institute

  collaborator OTHER

• University of Pavia

  collaborator OTHER

• Mario Negri Institute for Pharmacological Research

  collaborator OTHER

• Fondazione Golgi Cenci

  lead OTHER

Principal Investigators

• Antonio Guaita, MD · GolgiCenci Foundation

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

70 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-03-31

Primary Completion

2015-03-31

Completion

2015-06-30

Countries

• Italy

Study Locations