Cognitive training on people with dementia - a randomized controlled trial

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000976684
• Date of registration: 11/09/2014
• Prospective Registration: Yes
• Primary sponsor: Kaisu Pitkala
• Public title: Cognitive training on people with dementia - a randomized controlled trial
• Scientific title: Cognitive training on people with dementia in day care compared with normal day care on participants' cognition, health-related quality of life, physical functioning and use of health and social services
• Date of first enrolment: 22/09/2014
• Target sample size: 160
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614000976684.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Finland

Contacts

• Name: Prof Kaisu Pitkala

• Name: Prof Kaisu Pitkala

Key inclusion & exclusion criteria

Inclusion criteria: Dementia accoding to Clinical dementia rating (mild to moderate: 0.5 to 3).
Participating day center activities 2x /wk in Helsinki day care center.
Volunteer. Finnish speaking, not at terminal stage, ability to see, hear, read and write, and living at home. If at moderate or severe stage, caregiver's consent is required.
In substudy to fMRI: Alzheimer diagnosis (undergone detailed diagnostics for AD), mild to moderate dementia (CDR 0.5 to 2);
Exclusion criteria: No dementia, not participating in day center twice/wk; other native language but Finnish, not able to see or hear, read or write sufficiently to participate cognitive training.
Exclusion criteria for fMRI substudy: Key exclusion criteria in fMRI:
Subjects with any kind of metal fragments in the body should not have an MR scan without further safety controls. This includes e.g. any electronic, magnetic or mechanical implants (such as a cardiac pacemaker, infusion pumps or cochlear implants), aneurysm clips in the brain or other surgical clips, or prostheses (such as artificial heart valves or dentures).


Age minimum: No limit
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Dementia;
Dementia

Neurological - Dementias

Neurological - Alzheimer's disease

Intervention(s)

Cognitive training.
Cognitive training intervention uses tasks mainly focusing on executive functioning (cognitive flexibility, planning, speed of processing, reasoning and attention) thus stimulating presumably more frontal areas of the brain. The cognitive training program will be a clinically and neuropsychologically relevant modification of the cognitive remediation therapy (CRT) , which is a training based intervention aimed to improve cognitive processes on psychiatric patients (Wykes et al 1999). The tasks will be tailored according to the participants' level of cognitive abilities, interests and adherence. The cognitive training takes place twice a week in Helsinki day centres in groups of 1-5 participants. Participants perform predetermined paper and pencil tasks for 45-60 min/day. Their work is directed, supported and assessed by a day centre trained assistant who will be trained by a neuropsychologist. Participants will be transferred to day centres by taxis and they will be provided also the normal day centre program. The whole day care will take approximately 4-6 hours and it includes also socializing with other participants. The intervention lasts 12 weeks.

Primary Outcome(s)

Global cognition according to ADAS-Cog
[At 3 months and 9 months after randomization]

Health related quality of life according to 15D[At 3 months and 9 months after randomization]

Secondary Outcome(s)

alertness according to CIBIC-Plus[3 and 9 months after randomization]

language capabilities according to Verbal fluency-test[At 3 and 9 months after randomization]

Primary caregiver's health related quality of life according to RAND-36[at 3 and 9 months after randomization]

Attention according to FAB, Trail making A, Stroop test (shortened version)[3 and 9 months after randomization]

Primary caregiver's psychological well-being according to PWB[at 3 and 9 months after randomization]

Psychological well-being according to PWB[at 3 and 9 months after randomization]

Subtests of Wechsler Adult Intelligence Scale IV: (similarities, block design, digit span, digit symbol)[At 3 and 9 months after randomization]

Use and costs of health and social services will be gathered from hospital and social service documentations as well as medical records and death dates from the central registers [From baseline (randomization) to 24 months. ]

In a substudy 20 intervention + 20 patients with mild to moderate dementia (preferably Alzheimer disease) will undergo functional MRI at Aalto university Advanced Magnetic Imaging Centre (AMI) by 3T MRI (Magnetom Skyra, Siemens). We will use a visual n-back task during the fMRI with three load levels (0-back, 1-back and 2-back) in order to clarify the areas and intensity of patients’ brain areas involved with these tasks requiring attention and working memory. In the n-back task, memory load is increased in a parametric manner. At all memory load levels, the number of stimuli, and the number and type of responses remain the same. The memory load is modulated by changing the instruction given to the subject. The presentation of the stimuli is controlled by Presentation software (Neurobehavioral Systems, Inc.) which also collects information concerning responses (correct, incorrect, misses) and reaction times. The findings of intervention and control participants will be described and compared. [Baseline and post-intervention (3months) will be compared]

Daily functioning according to ADCS-ADL[At 3 months and 9 months after randomization]

Planning according to Clock-Drawing test[At 3 and 9 months after randomization]

Secondary ID(s)

None

Source(s) of Monetary Support

Helsinki University Central Hospital EVO funding

Ethics review

Status: Approved
Approval date:
Contact:

Helsinki University Central Hospital, Ethics Committee, Department of Medicine