Alzheimer DiseaseNCT03784183
Neuropsychological and Neurophysiological Effects of Cognitive Stimulation in Patients With Alzheimer's Disease and Mild Cognitive Impairment
A study testing Cognitive Stimulation (CS) in people with Alzheimer Disease, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
The present study aims to evaluate the effect of cognitive stimulation (CS) in participants with a diagnosis of moderate and mild Alzheimer's disease (AD) and mild cognitive impairment (MCI) compared to control subjects not receiving any non-pharmacological interventions. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Cognitive Stimulation (CS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteItaly
- Study dates
- 27 Sep 2018to 1 Oct 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- moderate AD participants
- Clinical diagnosis of probable AD (National Institute on Aging and Alzheimer's Association criteria)
- 1 < Clinical Dementia Rating Scale < 3
- 13 ≤ Mini-Mental State Examination < 20/30
- Modified Hachinski Ischaemic Scale (MHIS) ≤ 4
- Geriatric Depression Scale (GDS) ≤ 6
Show all 26Show fewer
- mild AD participants
- Clinical diagnosis of probable AD (National Institute on Aging and Alzheimer's Association criteria)
- Clinical Dementia Rating Scale = 1 (memory box score ≥ 0.5)
- 20 > Mini-Mental State Examination < 27/30
- Modified Hachinski Ischaemic Scale (MHIS) ≤ 4
- Geriatric Depression Scale (GDS) ≤ 6
- MCI participants
- Clinical diagnosis of probable AD (National Institute on Aging and Alzheimer's Association criteria)
- Clinical Dementia Rating Scale < 1 (memory box score ≥ 0.5)
- Mini-Mental State Examination ≥ 24/30
- Modified Hachinski Ischaemic Scale (MHIS) ≤ 4
- Geriatric Depression Scale (GDS) ≤ 6
- Exclusion Criteria for all the participants (moderate AD, mild AD and MCI):
- Any medical or neurological condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause of the subject's cognitive impairment.
- Clinically significant psychiatric illness (e.g., uncontrolled major depression, bipolar affective disorder) within 6 months prior to the enrolment.
- Any medications that, in the opinion of the Investigator, may contribute to cognitive impairment or impair the subject's ability to perform cognitive testing or complete study procedures.
- Contraindications to Transcranial Magnetic Stimulation (history of epilepsy or seizures/presence of pacemaker).
- Subject currently living in an organized care facility with extensive intervention and/or support of daily living activities.
- Inability to comply with study requirements and commitments
- Has not one informant/care partner who, in the Investigator's opinion, has frequent and sufficient contact with the subject as to be able to provide accurate information about the subject's cognitive and functional abilities.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Department of Human Neuroscience, Sapienza University of Rome
Rome, 00185
Carlo de Lena, MD, 0649914028 ext. 0039, carlo.delena@uniroma1.it
Alessandro Trebbastoni, MD, PhD, 3491496146 ext. 0039, alessandro.trebbastoni@uniroma1.it
About this study
Official title: A Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy of a Non-Pharmacological Intervention of Cognitive Stimulation in Subjects With Alzheimer's Disease and Mild Cognitive Impairment: The Brain Stimulation Project.
The present study aims to evaluate the effect of cognitive stimulation (CS) in participants with a diagnosis of moderate and mild Alzheimer's disease (AD) and mild cognitive impairment (MCI) compared to control subjects not receiving any non-pharmacological interventions. Treated participants will receive a structured CS consisting of a wide range of activities aimed at the general improvement of social functioning and the maintenance of cognitive functions. The study consists of a 24-week treatment phase and a follow-up period of 24 weeks. During the treatment period, patients will receive two CS sessions a week. At baseline, all the participants undergo an extensive neuropsychological evaluation and a neurophysiological assessment aimed at studying the frequency of spontaneous blinking (blink rate) and cortical excitability and synaptic plasticity by means of the transcranial magnetic stimulation (TMS). Neuropsychological and neurophysiological evaluations will be repeated at the end of the treatment (week 24) and at the end of the follow-up period (week 48) in order to evaluate short- and long-term effects of CS. The hypothesis of this research is that CS may improve cognition and the neurophysiological parameters studied in treated participants compared to those untreated.
- Conditions
- Alzheimer Disease
- Being tested
- Cognitive Stimulation (CS)
- Keywords
- Alzheimer's Disease, Mild Cognitive Stimulation, Non Pharmacological Intervention, Cognitive Stimulation, Transcranial Magnetic Stimulation, Blink Reflex, Neuropsychological Evaluation, Randomized Controlled Trial
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Stimulation (CS)Other
CS consists of a wide range of structured activities aimed at the general improvement of social functioning and the maintenance of different cognitive functions. It is a non-specific in-group approach that places particular emphasis on social interactions.
| Study group | Role | What they receive |
|---|---|---|
| moderate AD-experimental | Experimental | Experimental Intervention: The CS shall be carried out in groups (5-7 participants), twice a week. Each session lasts 90 minutes. CS sessions begin with a training for temporal and spatial orientation in which participants are asked to recognize and recall the date and the place with the help of some environmental aids (calendars, clocks, pictures and maps). Then the participants complete an array of cognitive tasks for memory, attention, language, visuo-spatial functions and executive functions. These tasks range from individual paper-and-pencil exercises to verbal-learning exercises that have to be solved by the group. Receives: Other: Cognitive Stimulation (CS) |
| mild AD-experimental | Experimental | Experimental Intervention: the same of the "moderate AD-experimental" arm Receives: Other: Cognitive Stimulation (CS) |
| MCI-experimental | Experimental | Experimental Intervention: the same of the "moderate AD-experimental" arm Receives: Other: Cognitive Stimulation (CS) |
| moderate AD-placebo | No intervention | Not described |
| mild AD-placebo | No intervention | Not described |
| MCI-placebo | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in global cognition as assessed by Mini Mental State Examination
Change from baseline in Mini Mental State Examination score at Week 24 and 48. This scale investigates global cognition. Scale range: 0-30. Normal values >24. Higher values represent a better outcome.
Measured: 24 and 48 weeks
Change in dementia severity as assessed by Clinical Dementia Rating Scale
Change from baseline in Clinical Dementia Rating Scale score at Week 24 and 48. This scale investigates global cognition and dementia severity. Scale range: 0-5. Normal values = 0. Higher values represent a worse outcome.
Measured: 24 and 48 weeks
Secondary outcomes (7)
Change in frontal functions as assessed by Frontal Assessment Battery
Change from baseline in Frontal Assessment Battery scores at Week 24 and 48. This scale investigates the executive functions. Scale range: 0-30. Normal values ≥ 13.5. Higher values represent a better outcome.
Measured: 24 and 48 weeks
Change in verbal memory as assessed by Rey Auditory Verbal Learning Test
Change from baseline in Rey Auditory Verbal Learning Test scores at Week 24 and 48. This test investigates verbal learning and memory. Immediate recall scale range: 0-75. Normal values >28.52. Delayed recall scale range: 0-15. Normal values >4.68. Higher values represent a better outcome.
Measured: 24 and 48 weeks
Change in attention as assessed by Visual Search Test
Change from baseline in Visual Search test score at Week 24 and 48. This test investigates selective attention. Scale range: 0-60. Normal values >30. Higher values represent a better outcome.
Measured: 24 and 48 weeks
Change in visuospatial functions as assessed by Clock Drawing Test
Change from baseline in Clock Drawing Test score at Week 24 and 48. This test investigates visuospatial abilities and executive functioning. Scale range: 0-61. Normal values >42.17. Higher values represent a better outcome.
Measured: 24 and 48 weeks
Change in naming as assessed by Boston Naming Test
Change from baseline in Boston Naming test score at Week 24 and 48. This test measure object naming from line drawings. Scale range: 0-60. Normal values >24. Higher values represent a better outcome.
Measured: 24 and 48 weeks
Change in synaptic plasticity as assessed by Paired Associative Stimulation
Change from baseline in Paired Associative Stimulation at Week 24 and 48. Paired associative stimulation is a paradigm combining peripheral nerve stimulation and transcranial magnetic stimulation over the contralateral primary motor cortex. In healthy humans, Paired Associative Stimulation after-effects last about 30-60 minutes. The extent of facilitatory-Paired Associative Stimulation-induced effects on MEP amplitude ranges from 120% to 160%, while inhibitory-Paired Associative Stimulation may induce a reduction of muscle-evoked potential amplitude that ranges from 60% to 90%.
Measured: 24 and 48 weeks
Change in blinking as assessed by Blink Rate Evaluation
Change from baseline in the blink rate at Week 24 and 48. Spontaneous blinking was measured by the Blink Rate and was expressed as number of blinks per minute. Normal values: mean Blink Reflex value at rest is 17 blinks/minute; during conversation is 26 blinks/minute; during reading is 4.5 blinks/minute. Cut offs: not applicable.
Measured: 24 and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start27 Sep 2018
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- A Randomized, Single-Blind, Placebo-Controlled, Parallel-Group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo de Lena, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784183
- Sponsor's protocol ID
- BSP-2018
- Status last verified
- Nov 2018
- First submitted
- 26 Nov 2018
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy of a Non-Pharmacological Intervention of Cognitive Stimulation in Subjects With Alzheimer's Disease and Mild Cognitive Impairment: The Brain Stimulation Project.
- ClinicalTrials.gov ID
- NCT03784183
- Acronym / sponsor ID
- BSP-2018
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer's Disease, Mild Cognitive Stimulation, Non Pharmacological Intervention, Cognitive Stimulation, Transcranial Magnetic Stimulation, Blink Reflex, Neuropsychological Evaluation, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 21 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study aims to evaluate the effect of cognitive stimulation (CS) in participants with a diagnosis of moderate and mild Alzheimer's disease (AD) and mild cognitive impairment (MCI) compared to control subjects not receiving any non-pharmacological interventions. Treated participants will receive a structured CS consisting of a wide range of activities aimed at the general improvement of social functioning and the maintenance of cognitive functions. The study consists of a 24-week treatment phase and a follow-up period of 24 weeks. During the treatment period, patients will receive two CS sessions a week. At baseline, all the participants undergo an extensive neuropsychological evaluation and a neurophysiological assessment aimed at studying the frequency of spontaneous blinking (blink rate) and cortical excitability and synaptic plasticity by means of the transcranial magnetic stimulation (TMS). Neuropsychological and neurophysiological evaluations will be repeated at the end of the treatment (week 24) and at the end of the follow-up period (week 48) in order to evaluate short- and long-term effects of CS. The hypothesis of this research is that CS may improve cognition and the neurophysiological parameters studied in treated participants compared to those untreated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
- Model description
- A Randomized, Single-Blind, Placebo-Controlled, Parallel-Group
| Arm | Type | Receives |
|---|---|---|
| moderate AD-experimental | Experimental | Other: Cognitive Stimulation (CS)Experimental Intervention: The CS shall be carried out in groups (5-7 participants), twice a week. Each session lasts 90 minutes. CS sessions begin with a training for temporal and spatial orientation in which participants are asked to recognize and recall the date and the place with the help of some environmental aids (calendars, clocks, pictures and maps). Then the participants complete an array of cognitive tasks for memory, attention, language, visuo-spatial functions and executive functions. These tasks range from individual paper-and-pencil exercises to verbal-learning exercises that have to be solved by the group. |
| mild AD-experimental | Experimental | Other: Cognitive Stimulation (CS)Experimental Intervention: the same of the "moderate AD-experimental" arm |
| MCI-experimental | Experimental | Other: Cognitive Stimulation (CS)Experimental Intervention: the same of the "moderate AD-experimental" arm |
| moderate AD-placebo | No intervention | – |
| mild AD-placebo | No intervention | – |
| MCI-placebo | No intervention | – |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- moderate AD participants
- mild AD participants
- MCI participants
- Any medical or neurological condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause of the subject's cognitive impairment.
- Clinically significant psychiatric illness (e.g., uncontrolled major depression, bipolar affective disorder) within 6 months prior to the enrolment.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Stimulation (CS)CS consists of a wide range of structured activities aimed at the general improvement of social functioning and the maintenance of different cognitive functions. It is a non-specific in-group approach that places particular emphasis on social interactions. | Other | MCI-experimental, mild AD-experimental, moderate AD-experimental |
Primary outcome
Change in global cognition as assessed by Mini Mental State Examination
Time frame: 24 and 48 weeks
Change from baseline in Mini Mental State Examination score at Week 24 and 48. This scale investigates global cognition. Scale range: 0-30. Normal values >24. Higher values represent a better outcome.
Change in dementia severity as assessed by Clinical Dementia Rating Scale
Time frame: 24 and 48 weeks
Change from baseline in Clinical Dementia Rating Scale score at Week 24 and 48. This scale investigates global cognition and dementia severity. Scale range: 0-5. Normal values = 0. Higher values represent a worse outcome.
7 secondary outcomes
Change in frontal functions as assessed by Frontal Assessment Battery
Time frame: 24 and 48 weeks
Change in verbal memory as assessed by Rey Auditory Verbal Learning Test
Time frame: 24 and 48 weeks
Change in attention as assessed by Visual Search Test
Time frame: 24 and 48 weeks
Change in visuospatial functions as assessed by Clock Drawing Test
Time frame: 24 and 48 weeks
Change in naming as assessed by Boston Naming Test
Time frame: 24 and 48 weeks
Change in synaptic plasticity as assessed by Paired Associative Stimulation
Time frame: 24 and 48 weeks
Change in blinking as assessed by Blink Rate Evaluation
Time frame: 24 and 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Human Neuroscience, Sapienza University of Rome
Rome, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Stimulation (CS) in people with Alzheimer Disease, run by University of Roma La Sapienza at 1 site in Italy.
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 26 inclusion and 0 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 21 Dec 2018. 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 Italy. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in global cognition as assessed by Mini Mental State Examination (time frame: 24 and 48 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 21 Dec 2018.