Alzheimer Disease Clinical Trial
Official title:
Comparison of 3 Learning Methods and Their Underlying Mechanisms to Improve Independent Living in the Activities of Daily Living in Alzheimer's Dementia: a Randomized Controlled Trial
This study is a comparison of 3 learning techniques, Errorless learning, modelling and trial
and error, in the relearning of IADL of Alzheimer patients from mild to moderately severe
dementia.
Tailored IADL will be chosen for each patient (n=300) and trained in individualized sessions
for 6 weeks.
This study focuses on the relationship between learning techniques, IADL and memory
processes, in a threefold way:
1. it will determine which of the of the three learning techniques (EL, MR, TE) will
improve most the (re)learning of instrumental skills in different dementia stages using
a randomized controlled trial;
2. it will explain the role of implicit and explicit memory mechanisms in the (re)learning
of IADL tasks; and
3. as a secondary objective, it will explore the possible drug treatment by behavioral
intervention interaction effects of the three learning techniques.
Scientific background and rationale Alzheimer dementia (AD) is the most common cause of
progressive cognitive deterioration that alters memory and learning to such a degree that it
heavily interferes with daily living. Functional autonomy loss is a key feature of AD, as it
follows a slow degradation process in cognitive function and in the ability to perform
instrumental activities of daily living (IADL), such as managing finance, food preparation
or using a dish washer. Normally, learning occurs in an unstructured manner, which consists
of guessing and the occurrence of errors during acquisition (Trial and Error, TE). However,
there is abundant evidence that reducing errors during learning (Errorless Learning, EL) or
increasing the time period between recall attempts (Modeling with Spaced Retrieval, MR)
allow even moderate and severe Alzheimer Dementia (AD) patients to (re)learn instrumental
activities of daily living (IADL) such as using a new route, an agenda or a cassette/radio
player. While these findings are encouraging, we still do not fully understand the memory
mechanisms underlying different learning techniques that are crucial in improving IADL tasks
(re)learning and remembering in AD patients. Because acetyl cholinesterase inhibitors or
memantine may be active moderators of intervention targeting memory improvement, complex
intervention using behavioral enrichment training should explore any drug treatment by
behavioral intervention interaction effects.
Description of the project methodology
This study focuses on the relationship between learning techniques, IADL and memory
processes, in a threefold way:
1. it will determine which of the of the three learning techniques (EL, SR, TE) will
improve most the (re)learning of instrumental skills in different dementia stages using
a randomized controlled trial;
2. it will explain the role of implicit and explicit memory mechanisms in the (re)learning
of IADL tasks.; and
3. it will explore the possible drug treatment by behavioral intervention interaction
effects of the three learning techniques.
- Primary outcome :
Is the (re)learning effectiveness (physical performance) of each procedure and the overall
maintain of the autonomy. All intervention are individualized training. The learning
procedure comparison will allow us to assess the (re) learning capacities of IADL tasks in
AD patients according to severity stages from mild to moderately severe.
• Secondary outcome : Assessing the role of the implicit memory processes over the explicit
memory processes in the (re)learning of IADL tasks. Overall effects of the intervention over
the patient's autonomy, cognitive functioning, behavioral disturbances, quality of life and
careers burden.
Settings: Nursing Homes, Day Care centers, Memory Clinics Locations: Nijmegen, The
Netherlands and Nice and Bordeaux agglomerations, France 3 different interventions given in
individual sessions at participant's facility.
Each intervention is a 6-week training with a post assessment at 4-week follow-up. Each
participant will receive one of the 3 interventions for 2 hours twice a week in individual
sessions.
Errorless learning(EL) refers to the use of feedforward instruction (i.e., how to do) before
actions to prevent learners from making mistakes.
Modeling with Spaced Retrieval (MR) techniques refers to the modeling of the steps and the
increasing time interval between the completion of the task and the rehearsal of the
targeted information by the patient.
Trial and Error (TE) refers to the regular unstructured learning and is considered as
control condition.
A standardized 1-week training has been developed in French and Dutch to train French and
Dutch therapists at each learning techniques.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention
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