Alzheimer DiseaseSemantiMATTNCT03047694
A Lexico-semantic Program on Tactile Tablet for Patients With Alzheimer's Disease
A study testing tablet therapy in people with Alzheimer Disease, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
Lexical semantic disorders are described in Alzheimer's disease, and their incidence in everyday life is important to the extent that these disorders affect expression and comprehension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- tablet therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Jul 2019to 15 Jan 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major Patient
- Patient with a diagnosis of Alzheimer's disease according to DSM-IV and NINCDS-ADRDA criteria.
- Patient at a moderate stage of the disease: Score at CDR (Clinical Dementia Rating Scale) between 0.5 inclusive and 2 inclusive and MMS score greater than or equal to 10 and lower strictly at 27
- Lexical-semantic disorder
- Treatment with pro-cognitive drugs at stable doses for at least 3 months,
- Speech therapy in progress (2 or 3 sessions per week)
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- Patient with free and informed consent
- Affiliated to the Health care system
- Native french speaker,
- Attendance of a caregiver.
- For the early onset group, patients should have started the disease before 65 years of age. The randomization will be stratified according to age (<65 years or> 65 years), enabling to include 2 groups of identical size of young AD (Alzheimer Disease) and Late (Alzheimer Disease) patients, each half distributed in the tablet or control group.
Who cannot join
- Other known neurological disease or general illness or major psychic problems that may interfere with cognitive functioning,
- Patient under guardianship or curatorship
- Confusion,
- Cerebral MRI (or scanner for contraindication to MRI), obtained in the context of routine care compatible with a pathological process other than that related to Alzheimer's disease. A discrete or moderate leukoaraiosis (stages 1 and 2 of Fazekas) will not be considered as a criterion of non-inclusion.
- Uncorrected hearing or visual impairment
- Inclusion in another intervention protocol.
- Participation in an additional stimulation workshop
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Pitié-Salpêtriere
Paris, 75013
APHP - Pitié-Salpêtrière Hospital
Paris, 75651
About this study
Official title: Contribution of a Semantic Therapy on a Tactile Tablet in the Alzheimer's Disease, Early and Late Onset
Lexical semantic disorders are described in Alzheimer's disease, and their incidence in everyday life is important to the extent that these disorders affect expression and comprehension.
Providing a tactile tablet stimulation, independent and complementary to speech therapy, could help to maintain certain abilities and reinforce the feeling of autonomy of the patients.
Read the detailed description
It is a monocentric, controlled, randomized, parallel-group, single-blind clinical trial.
For each of the two forms of Alzheimer's Disease (young or late), it compares two groups of patients: a group benefiting from a tactile tablet semantic stimulation (tablet group) and a control group All patients benefit from a clinical evaluation and a language assessment at M0, M3 and M6. The analyzes will be conducted in intention to treat.
The main criterion is the 3-month variation of the Lexis 3 subtests scores. The two groups will be compared by the Student test.
The number of subjects required is based on the following assumptions: a 10% increase over three months of the Lexis subtests scores in the tablet group and a stability of the scores in the control group. The standard deviation of the variation is assumed to be identical in both groups and equal to 13% at the most. Three scores being compared, tests will be conducted at the 1.67% threshold (Bonferroni correction) to ensure a 5% overall risk of first species. The inclusion of 36 patients in each of the two treatment groups will give 80% power to the study.
- Conditions
- Alzheimer Disease
- Being tested
- tablet therapy, usual care
- Keywords
- Lexico-semantic stimulation, tactile tablet
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tablet therapyOther
Also called Experimental Arm
stimulation of the lexico semantic system on a tactile tablet therapy for 3 months
usual careOther
Also called speech therapy
speech therapy
| Study group | Role | What they receive |
|---|---|---|
| Tablet group | Experimental | Patients will continue their usual care (1 or more sessions of weekly speech therapy) and will benefit from the therapy on tablet for 3 months. Receives: Other: tablet therapy |
| Control group | Active comparator | Patients will continue their usual care (1 or more sessions of weekly speech therapy) Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
variation of performance on naming subtest of the LEXIS
Measured: variation from baseline at 3 month
variation of performance on designation subtest of the LEXIS
Measured: variation from baseline at 3 month
variation of performance on semantic matching subtest of the LEXIS
Measured: variation from baseline at 3 month
Secondary outcomes (10)
variation of performance on DO80 lexico-semantic test
Measured: variation from baseline at 3 month and 6 month
variation of performance on verbal fluency lexico-semantic test
Measured: variation from baseline at 3 month and 6 month
variation of performance on verbal discrimination of BADAE
Measured: variation from baseline at 3 month and 6 month
variation of performance on episodic memory test (RL/RI)
Measured: variation from baseline at 3 month and 6 month
variation of performance on Mini-Mental State Examination (MMSE)
Measured: variation from baseline at 3 month and 6 month
variation of score on depression scale (HAD)
Measured: variation from baseline at 3 month and 6 month
variations on care giver's questionary
Measured: variation from baseline at 3 month and 6 month
variation of performance on naming subtest of the LEXIS
Measured: variation from 3 month at 6 month
variation of performance on designation subtest of the LEXIS
Measured: variation from 3 month at 6 month
variation of performance on semantic matching subtest of the LEXIS
Measured: variation from 3 month at 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start15 Jul 2019
- Primary completion15 Jan 2021
- Study completion15 Jan 2021
Why it stopped: Lack of inclusion
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 Assistance Publique - Hôpitaux de ParisThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agnès MICHON, MD, Principal investigator, Assistance Publique Hoptiaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047694
- Sponsor's protocol ID
- P140707
- Other IDs
- 2015-A01312-47
- Acronym
- SemantiMATT
- Status last verified
- Apr 2023
- First submitted
- 23 Dec 2016
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of a Semantic Therapy on a Tactile Tablet in the Alzheimer's Disease, Early and Late Onset
- ClinicalTrials.gov ID
- NCT03047694
- Acronym / sponsor ID
- SemantiMATT / P140707
- Conditions
- Alzheimer Disease
- Keywords
- Lexico-semantic stimulation, tactile tablet
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of inclusion
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 9 Feb 2017 (estimated)
- 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.
Lexical semantic disorders are described in Alzheimer's disease, and their incidence in everyday life is important to the extent that these disorders affect expression and comprehension.
Providing a tactile tablet stimulation, independent and complementary to speech therapy, could help to maintain certain abilities and reinforce the feeling of autonomy of the patients.
Detailed description
It is a monocentric, controlled, randomized, parallel-group, single-blind clinical trial.
For each of the two forms of Alzheimer's Disease (young or late), it compares two groups of patients: a group benefiting from a tactile tablet semantic stimulation (tablet group) and a control group All patients benefit from a clinical evaluation and a language assessment at M0, M3 and M6. The analyzes will be conducted in intention to treat.
The main criterion is the 3-month variation of the Lexis 3 subtests scores. The two groups will be compared by the Student test.
The number of subjects required is based on the following assumptions: a 10% increase over three months of the Lexis subtests scores in the tablet group and a stability of the scores in the control group. The standard deviation of the variation is assumed to be identical in both groups and equal to 13% at the most. Three scores being compared, tests will be conducted at the 1.67% threshold (Bonferroni correction) to ensure a 5% overall risk of first species. The inclusion of 36 patients in each of the two treatment groups will give 80% power to the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tablet group | Experimental | Other: tablet therapyPatients will continue their usual care (1 or more sessions of weekly speech therapy) and will benefit from the therapy on tablet for 3 months. |
| Control group | Active comparator | Other: usual carePatients will continue their usual care (1 or more sessions of weekly speech therapy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Major Patient
- Patient with a diagnosis of Alzheimer's disease according to DSM-IV and NINCDS-ADRDA criteria.
- Patient at a moderate stage of the disease: Score at CDR (Clinical Dementia Rating Scale) between 0.5 inclusive and 2 inclusive and MMS score greater than or equal to 10 and lower strictly at 27
- Lexical-semantic disorder
- Treatment with pro-cognitive drugs at stable doses for at least 3 months,
Key exclusion criteria (7 listed)
- Other known neurological disease or general illness or major psychic problems that may interfere with cognitive functioning,
- Patient under guardianship or curatorship
- Confusion,
- Cerebral MRI (or scanner for contraindication to MRI), obtained in the context of routine care compatible with a pathological process other than that related to Alzheimer's disease. A discrete or moderate leukoaraiosis (stages 1 and 2 of Fazekas) will not be considered as a criterion of non-inclusion.
- Uncorrected hearing or visual impairment
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 |
|---|---|---|
| tablet therapyAlso: Experimental Armstimulation of the lexico semantic system on a tactile tablet therapy for 3 months | Other | Tablet group |
| usual careAlso: speech therapyspeech therapy | Other | Control group |
Primary outcome
variation of performance on naming subtest of the LEXIS
Time frame: variation from baseline at 3 month
variation of performance on designation subtest of the LEXIS
Time frame: variation from baseline at 3 month
variation of performance on semantic matching subtest of the LEXIS
Time frame: variation from baseline at 3 month
10 secondary outcomes
variation of performance on DO80 lexico-semantic test
Time frame: variation from baseline at 3 month and 6 month
variation of performance on verbal fluency lexico-semantic test
Time frame: variation from baseline at 3 month and 6 month
variation of performance on verbal discrimination of BADAE
Time frame: variation from baseline at 3 month and 6 month
variation of performance on episodic memory test (RL/RI)
Time frame: variation from baseline at 3 month and 6 month
variation of performance on Mini-Mental State Examination (MMSE)
Time frame: variation from baseline at 3 month and 6 month
variation of score on depression scale (HAD)
Time frame: variation from baseline at 3 month and 6 month
variations on care giver's questionary
Time frame: variation from baseline at 3 month and 6 month
variation of performance on naming subtest of the LEXIS
Time frame: variation from 3 month at 6 month
variation of performance on designation subtest of the LEXIS
Time frame: variation from 3 month at 6 month
variation of performance on semantic matching subtest of the LEXIS
Time frame: variation from 3 month at 6 month
Results and safety
The study was stopped early (reason given: Lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
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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.
Agnès MICHON, MD principal investigator
Assistance Publique Hoptiaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tablet therapy in people with Alzheimer Disease, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
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 11 inclusion and 7 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: stopped early, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
The study was stopped early (reason given: Lack of inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variation of performance on naming subtest of the LEXIS (time frame: variation from baseline at 3 month). The study lists 3 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 24 Apr 2023.