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Alzheimer DiseaseNCT04220593

Effects of Transcranial Direct Current Stimulation Associated With Cognitive Training in Alzheimer's Disease

A study testing tDCS associated with Tcog in people with Alzheimer Disease, run by Federal University of Paraíba at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Alzheimer's disease (AD) is characterized by a progressive decline in cognitive functions, interfering with autonomy and independence. According to the Diagnostic and Statistical Manual of Mental Disorders (DSM 5), mnemonic dysfunction in AD must be related to aphasia, apraxia, agnosia, or changes in executive… Read more about this study

Who is it for?
Ages 55 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Alzheimer Disease
What is being tested?
tDCS associated with Tcog
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteBrazil
Study dates
25 Nov 2019to 1 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

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 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients will be included in this study following the following requirements: (a) age between 55 and 85 years; (b) probable diagnosis AD; (c) scores higher than 18 on the Mini Mental State Examination (MMSE); (e) did not receive regular cognitive intervention within 3 months prior to the start of this clinical trial.

Who cannot join

  • Patients will be excluded from this study while not meeting the following criteria: (a) individuals with severe metabolic and / or cardiac disorders, alcoholism, focal neurological disorders and associated psychiatric disorders; (b) use of hypnotics and benzodiazepines two weeks prior to study initiation; or (c) use of medication with cholinergic inhibitors and memantine for more than two months prior to this clinical trial; (d) or with any condition that could impair the neuropsychological assessment process or receive a cognitive intervention protocol from the study will be excluded from the study. In addition, participants with transient or definitive pacemakers, cochlear implants, or intracranial aneurysm clips will be excluded; (e) individuals with a history of seizures; (f) the presence of tumors, epilepsy or substance abuse.

Trial locations and contacts

1 site in 1 country.

Brazil1 site, 1 recruiting
  • Suellen Andrade

    João Pessoa, Paraíba

    Suellen Andrade, +55 83 999371471, suellenandrade@gmail.com

    Gabriella Conserva, +55 83 98747-1386, gabriellac.to@gmail.com

    Recruiting

Other trials in Brazil

About this study

Official title: Effects of Transcranial Direct Current Stimulation Associated With Cognitive Training in Alzheimer's Disease: Clinical Trials, Triple-blind and Randomized

Alzheimer's disease (AD) is characterized by a progressive decline in cognitive functions, interfering with autonomy and independence. According to the Diagnostic and Statistical Manual of Mental Disorders (DSM 5), mnemonic dysfunction in AD must be related to aphasia, apraxia, agnosia, or changes in executive function. The clinical picture of the disease can be described as mild, moderate and severe. In the mild phase, the patient is disoriented and with difficulties in thinking, in later stages memory lapses become more intense and frequent. The symptoms of apraxia, aphasia and agnosia appear, causing a noticeable impact on the performance of simple daily activities, and neuropsychiatric and behavioral symptoms are expressed. Existing pharmacological treatments for AD treatment are able to minimize the symptoms of the disease, but are not able to promote cure. Therefore, studies have sought to better understand non-pharmacological strategies, aiming at optimizing the benefits of using the drug. Studies have suggested that tDCS promotes significant effects on cognitive processes assessed through cognitive tasks, not only in healthy individuals but also in clinical populations. Cognitive training (TCog) has similarly shown excellent results in the treatment of cognitive deficits due to AD. Thus, the present study aims to investigate when (before, during or after) the tDCS should be applied to potentiate the effects of TCog in people with AD by comparing four protocols of application of neurostimulation associated with TCog.

Read the detailed description

It consists of a randomized, triple-blind, placebo-controlled clinical trial. The AETCC must be associated with the Tcog. Patients diagnosed in mild to moderate AD will be randomized into four groups: G1, aETCC before TCog; G2, aETCC during TCog; G3 aETCC after TCog and G4: simulated aETCC during TCog. Groups G1, G2 and G3 will receive the active current, while G4 will receive the simulated current. In each condition, an initial baseline assessment (T0) will be performed after 12 sessions (T1) and three weeks after the end of interventions (T2). The outcomes evaluated will be: cognition, executive function, functionality, neuropsychiatric symptoms and occupational performance. For all analyzes, SPSS (Statistical Package for Social Sciences - SPSS Inc, Chicago IL, USA) for Windows, Version 20.0, will be used and considered as significant, an alpha value of 5% (p <0.05 ).

Being tested
tDCS associated with Tcog
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tDCS associated with TcogOther

    2mA-intensity aETCC will be applied to the left dorsolateral prefrontal cortex (CPFDL) region for 20 min, three times a week (every other day) over a one-month period, totaling 12 sessions. In each session activities aimed at stimulating cognition will be applied over the 20 minutes.

Study groups in NCT04220593
Study groupRoleWhat they receive
aETCC before TCogExperimentalAnodic transcranial direct current stimulation (tDCS) over left dorsolateral prefrontal cortex (DLPFC) associated with cognitive training (Tcog). Duration: 20 minutes; Intensity: 2mA.
Receives: Other: tDCS associated with Tcog
aETCC during TCogExperimentalAnodic transcranial direct current stimulation (tDCS) over left dorsolateral prefrontal cortex (DLPFC) associated with cognitive training (Tcog). Duration: 20 minutes; Intensity: 2mA.
Receives: Other: tDCS associated with Tcog
aETCC after TCogExperimentalAnodic transcranial direct current stimulation (tDCS) over left dorsolateral prefrontal cortex (DLPFC) associated with cognitive training (Tcog). Duration: 20 minutes; Intensity: 2mA.
Receives: Other: tDCS associated with Tcog
Simulated aETCC during TCogSham comparatorAnodic transcranial direct current stimulation (tDCS) over left dorsolateral prefrontal cortex (DLPFC) associated with cognitive training (Tcog). Duration: 20 minutes; Intensity: 2mA.
Receives: Other: tDCS associated with Tcog

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in global cognitive function by the Alzheimer's Disease Assessment Scale (ADAS-Cog)

    Cognitive Scale of the Alzheimer's Disease Assessment Scale (ADAS-Cog), consisting of 11 items that assesses performance related to memory, language, praxis and comprehension skills, with a maximum score of 70 points. Thus, the higher the score, the more compromised the individual is. Application takes about 30 minutes (Mohs \& Cohen, 1988). In addition, the Montreal Cognitive Assessment (MoCA), a cognitive screening tool created by Nasreddine et al. (2005).

    Measured: baseline, after 4 weeks and after 12 weeks

  2. Change in global cognitive function by the Montreal Cognitive Assessment (MoCA)

    MoCA is composed of eight cognitive domains, which are scored within a range of 0 to 30 points (higher scores indicate better function): short-term memory; visuospatial skills; executive function; verbal fluency; attention, concentration and working memory; language; sentence repetition; and spatiotemporal orientation.

    Measured: baseline, after 4 weeks and after 12 weeks

Secondary outcomes (5)
  1. Change in Executive Function by the Trail Making Test (TMT)

    The Trail Making Test (TMT) will be administered (Reitan, 1958). From a clinical point of view, TMT is widely used as an indicator of brain dysfunction. TMT is divided into two parts, TMT-A and TMT-B. In the first, circles numbered 1 to 25 following the randomly arranged numerical sequence should be connected, time taken and considered, ie the task should be performed as soon as possible. In the TMT-B task, the connection must alternate between numbers and letters. The TMT (AB) scores consist of the time taken to complete each part, other derived scores are used, such as the difference score (TMT-B - TMT-A) and the ratio score (TMT-A) / TMT- B) (Llinàs-Reglà et al, 2015).

    Measured: baseline, after 4 weeks and after 12 weeks

  2. Change in Executive Function by the Tower of London

    The Tower of London (Shallice, 1982) has been used in studies to evaluate executive function in elderly with AD (Satler, Guimarães, Tomaz, 2016). Tower of London is made up of three vertical pins of different heights and three colored spheres, with a hole in the center to fit the pins. The goal is to move them to reproduce, in a given number of moves, the position of a presented target figure. There are 15 problems with increasing difficulty and reduced possibilities for moving parts. Three attempts to resolve the issue are allowed. Will be evaluated: total and average execution time, and total score, obtained by the sum of the points of each step, ranging from 0 to 3.

    Measured: baseline, after 4 weeks and after 12 weeks

  3. Change in Functionality by the Disability Assessment for Dementia (DAD)

    Disability Assessment for Dementia (DAD) (Gauthier, et al., 1997; Gélinas et al., 1999). The DAD comprises 17 items that assess ADLs and 23 items that assess instrumental ADL (iADL) and leisure activities. In the category related to ADLs are evaluated hygiene, dressing, undressing, continence and food. IADL assessment and leisure activities consist of tasks related to meal preparation, phoning, sightseeing, finances and correspondence, medication and leisure, and housework (Feldman et al. (2001; Suh et al., 2004). maximum score is 100, lower scores indicate higher level of impairment (Bahia et al., 2010).

    Measured: baseline, after 4 weeks and after 12 weeks

  4. Change in Neuropsychiatric symptoms by the Neuropsychiatric Inventory Questionnaire (NPI-Q)

    This outcome will be assessed with the Neuropsychiatric Inventory Questionnaire (NPI-Q; Kaufer et al., 2000). This instrument consists of a self-administered caregiver scale and provides information on 12 characteristic behavioral and psychological symptoms in patients with dementia. The severity level will be identified (1 = mild, 2 = moderate, 3 = severe). The overall severity score ranges from 0 to 36, with zero indicating no neuropsychiatric symptoms. The reliability and validity of this modified NPI score have been previously established (NPI-Q; Kaufer et al., 2000).

    Measured: baseline, after 4 weeks and after 12 weeks

  5. Change in Occupational performance by theCanadian Occupational Performance Measure (COPM)

    The Canadian Occupational Performance Measure (COPM) (Law et al., 2009) will be used to assess occupational performance, ie engagement in daily activities. The COPM is can be applied with the patient or caregiver, following four steps, firstly it seeks to identify which areas of occupational performance are impaired, ie, which occupations are compromised, and then assign a value from 1 to 10 to measure the degree of importance that the activities listed have for the interviewee or caregiver. Next, five of these activities are organized by priority, and each of them should be assigned a value between 1 and 10 to describe the interviewee's performance and satisfaction respectively. In the end, the averages of performance and satisfaction are calculated.

    Measured: baseline, after 4 weeks and after 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2020
  2. Study start25 Nov 2019
  3. Primary completion1 Oct 2020 (estimated)
  4. Study completion1 Dec 2020 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04220593
Sponsor's protocol ID
CogAD
Status last verified
Jan 2020
First submitted
26 Nov 2019
Last updated
7 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing tDCS associated with Tcog in people with Alzheimer Disease, run by Federal University of Paraíba at 1 site in Brazil.

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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Suellen Andrade (+55 83 999371471, suellenandrade@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in global cognitive function by the Alzheimer's Disease Assessment Scale (ADAS-Cog) (time frame: baseline, after 4 weeks and after 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 7 Jan 2020.

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