Acquired Brain Injury (Including Stroke)NCT06774287
Evaluation of the Karman Line Memory Strategy Training
A study testing Karman Line memory strategy training and Treatment as usual in people with Acquired Brain Injury (Including Stroke), run by Klimmendaal Revalidatiespecialisten at 1 site in Netherlands.
Trial summary
Rationale: Acquired brain injury (ABI) often results in memory deficits that can have a big impact on social and vocational functioning of patients. Rehabilitation treatment of memory dysfunction consists of optimizing memory performance by using effective compensation strategies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acquired Brain Injury (Including Stroke)
- What is being tested?
- Karman Line memory strategy training and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Jan 2025to 15 Apr 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of subjective memory complaints. Memory complaints will be operationalized as ≥1 standard deviation on the total score of the EMQ-R questionnaire in comparison with the healthy control norm.
- presence of mild to moderate objective memory deficits, objectified with neuropsychological assessment for clinical purposes. Mild to moderate memory deficits will be operationalized as test score ≥1 standard deviation (SD) and <2 SD in comparison to the normative mean on at least two separate memory measures and no more than one measure ≥ 2SD. For each task the norm data that is described in the test manual will be used.
- Age: 18-75 years
- Non-progressive acquired brain injury
- Minimal time post-onset of 3 months
- Outpatient rehabilitation
- Living independently at home
- Premorbid functioning: score 4 on the Verhage scale
Who cannot join
- Severe memory deficits
- Inability to speak and/or understand the Dutch language
- Severe disorders in executive functioning
- Severe psychiatric problems
- Neurodegenerative disorders
- Substance abuse
Show all 12Show fewer
- Aphasia
- Neglect
- No access to a smartphone and a tablet/laptop with internet connection
- Unable to look at a computer screen for 15 minutes
- Unable to operate a keyboard or computer mouse.
- No informed consent
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Klimmendaal Revalidatiespecialisten
Arnhem, Gelderland, 6813 GG
About this study
Official title: Evaluation of the Karman Line Memory Strategy Training, a Combined Computerized and Face-to-face Compensatory Treatment Targeting Memory Complaints After Acquired Brain Injury, Using Single-case Experimental Design Methodology
Rationale: Acquired brain injury (ABI) often results in memory deficits that can have a big impact on social and vocational functioning of patients. Rehabilitation treatment of memory dysfunction consists of optimizing memory performance by using effective compensation strategies. Several effective memory-strategy training programs have been developed. However, these often contain labor-intensive treatment protocols that are possibly an overtreatment of ABI patients with relatively mild memory impairments. On the other hand there is a sprawl of commercial computerized cognitive training programs or 'brain games' available that claim to restore memory function. However, research has repeatedly shown that treatment effects of available brain games do not generalize to daily life functioning. With the shortcomings of current memory treatment programs in mind, the investigators developed a combined computerized and face-to-face training of memory strategies, which consists of a shortened traditional face-to-face treatment combined with an innovative Brain Game based on compensation strategies instead of restorative training. This is a promising cost-effective intervention that provides the possibility of repeated practice at home to train compensatory strategies in a safe and imaginative digital environment. The hypothesis is the strategy training will promote generalization, also after rehabilitation ends.
Objective: The primary objective is the evaluation of the potential positive effect of the combined computerized and face-to-face memory treatment on effective memory strategy use and reducing subjective memory failures in ABI patients with memory deficits in the chronic phase of acquired brain injury (>3 months after injury).
Read more
Study design: The study will be a multiple-baseline across individuals single-case experimental design (SCED). Three patients will receive treatment as usual and three patients will receive a shortened treatment combined with the game, which will be referred to as the 'Karman Line memory strategy training'.
Study population: The study population consists of patients referred for outpatient cognitive rehabilitation. Participants eligible for the study must have memory deficits and complaints due to Acquired Brain Injury (ABI) of nonprogressive nature (i.e. TBI, stroke), with a minimum time post-onset of 3 months. Age has to be between 18 and 75 and participants have to live independently at home. Memory deficits will be assessed by neuropsychological examination, memory complaints will be assessed by the Everyday Memory Questionnaire-Revised (EMQ-R). In one year six to eight participants will be recruited.
Intervention: The Karman Line memory strategy training consists of six weekly treatment sessions under the guidance of a therapist. The protocol is a shortened version of an existing memory strategy training (treatment as usual), which contains ten sessions. In the sessions, patients get information about memory and memory strategies and learn to apply those to their personal treatment goals. Inbetween the sessions, the participant will work on personal memory goals and practice the strategies by playing the corresponding levels of the memory game at home.
Main study parameters/endpoints: The main study parameter is the three most commonly reported memory complaints selected from the 13-item scale of the EMQ-R. The primary outcome measure is not the EMQ-R, but a personalized set of measurement VAS-scales for each patient. Secondary study parameters include the impact of memory problems on activities and participation, the achievement of personalized treatment goals, objective strategy use, objective memory functioning, metacognitions about memory and measures of feasibility by patients and practitioners.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden in the study consists of participating in repeated measurements, therapy sessions, and homework assignments. All tests and methods that are used are non-invasive and not stressful for the patient. All tests and tasks will be based on widely-used validated and reliable paper-pencil or computer tasks. Treatment is non-invasive and scarcely stressful: a therapist will always be present and assess the patient's burden and eventually take appropriate measures such as inserting a resting break.
- Conditions
- Acquired Brain Injury (Including Stroke)
- Being tested
- Karman Line memory strategy training, Treatment as usual
- Keywords
- Compensatory brain games, Acquired Brain Injury, memory disorder
- Medical subject headings
- Brain Injuries, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Karman Line memory strategy trainingBehavioural
The memory strategy training consists of six weekly face-to-face treatment sessions. After sessions 3-5, the participant will play 8 levels in total of the Karman Line memory game on their computer or mobile device. In these levels they practice the strategies that are introduced in the face-to-face treatment in a safe digital environment. Also, the Karman Line memory app is provided.
Treatment as usualBehavioural
Treatment as usual contains ten sessions, with nine obligatory sessions supplemented with 1 (of five) non-obligatory sessions. Which non-obligatory sessions is chosen is dependent on the patients treatment goals.
| Study group | Role | What they receive |
|---|---|---|
| treatment as usual | Active comparator | Treatment as usual contains 10 memory strategy sessions (two sessions per week) with a therapist in the rehabilitation centre. Receives: Behavioral: Treatment as usual |
| Karman Line memory training | Experimental | Karman Line memory strategy training contains 6 weekly memory strategy sessions in the rehabilitation centre, combined with practicing digital games at home and using a memory app. Receives: Behavioral: Karman Line memory strategy training |
What is being measured
The primary outcome is the main question the study is designed to answer.
memory complaints
The 13-item scale of the everyday memory questionnaire-revised (EMQ-R) is used to select the three most common memory complaints that are targeted with the intervention. The primary outcome measure is not the EMQ-R, but a personalized set of measurement visual analogue scales (VAS) for each patient. The total score (range 0-30) will be used as outcome measure. A higher score indicates more memory complaints, which is a worse outcome.
Measured: every other day during 8-10 weeks, weekly during 3-5 weeks
Secondary outcomes (16)
The impact of memory problems on activities and participation
visual analogue scale (range 0-10), 10 meaning more impact on activities and participation
Measured: every other day during 8-10 weeks, weekly during 3-5 weeks
The achievement of personalized treatment goals
The achievement of personalized treatment goals is measured by goal attainment scaling (GAS). GAS is a mathematical technique for quantifying the achievement of goals set, used in rehabilitation. GAS is described as a method of scoring the extent to which a patient's individual goals are achieved in the course of intervention. In effect, each patient has their own outcome measure, but this is scored in a standardized way. The achievement of each goal can be measured on a 5-point scale ranging from -2 to +2. Outcomes can be quantified in a single aggregated Goal Attainment Score. This method gives a numerical T-score which is normally distributed about a mean of 50 (if the goals are achieved precisely) with a standard deviation of around this mean of 10 (if the goals are overachieved or underachieved). Goals are individually identified to suit and the levels are individually set around their current and expected levels of performance.
Measured: 4 measurements during study participation (during 13 weeks)
Objective strategy use task
The original strategy observation task (SOT )is developed to observe strategy use during a memory task that mimics daily life situations. For repeated measurements, parrallel versions are used. Participants are instructed to remember a story that was played as an audio clip. Additionally, participants are asked to spontaneously recall the story exactly 5 min after the end of the audio clip. In the meantime, they are instructed to solve basic math problems. The instructions emphasize that participants should remember as much information as possible and that they are allowed to do or use anything to help them remember the information. The strategic behavior of the participants is recorded on an observation list.
For analyses, the total number of strategies on the SOT is used, including both observed and self-reported strategies.
Measured: 4 measurements during study participation (during 13 weeks)
Rivermead Behavioural Memory Test-3 (RBMT-3-NL)
The RBMT-3-NL is a valid ecologically valid memory batty that is usable for repeated measurement of memory. An overall General Memory Index can also be derived which has a mean of 100 and standard deviation of 15.
Measured: 2 measurements during study participation (during 13 weeks)
Location Learning Test (LLT)
The LLT is a test that can be used to measure episodic spatial memory for object locations. Normalized scores for immediate and delayed spatial memory are computed (percentiles 0-100).
Measured: 2 measurements during study participation (during 13 weeks)
Verbal learning and memory test (VLGT).
The VLGT is the Dutch translation of the internationally widely used Californian Verbal Learning Test (CVLT) and is designed to assess encoding, recall, and recognition of auditory-verbal information. Normalized scores for immediate and delayed verbal memory are computed (percentiles 0-100).
Measured: 2 measurements during study participation (during 13 weeks)
Delis-Kaplan Executive Function System Color Word Interference Test (D-KEFS CWIT)
The D-KEFS CWIT contains measures of attention and information processing speed (conditions 1 and 2) and executive functioning, more specifically inhibition and cognitive flexibility (conditions 3 and 4). Normalized standard scores can be computed (range 0-19, mean: 10, standard deviation: 3).
Measured: 2 measurements during study participation (during 13 weeks)
Wechsler Memory Scale IV-NL Symbol span
Symbol span is a measure of visual working memory. Normalized standard scores can be computed (range 0-19, mean: 10, standard deviation: 3).
Measured: 2 measurements during study participation (during 13 weeks)
Wechsler Adult Intelligence Scale IV-NL digit span (WAIS-IV-NL DS)
The digit span is a measure of verbal working memory. Normalized standard scores can be computed (range 0-19, mean: 10, standard deviation: 3).
Measured: 2 measurements during study participation (during 13 weeks)
Cognitive Failure Questionnaire (CFQ)
The CFQ is a commonly used self-report measure of cognitive errors experienced in daily life . The questionnaire consists of 25 items, rated on a 5-point scale (range 0-125, higher score meaning more cognitive errors). Four additional questions inform on potential increases in the occurrence of these mistakes and the extent to which an individual finds these experiences troublesome, annoying, or worrisome.
Measured: 4 measurements during study participation (during 13 weeks)
Strategy Use in daily life Inventory (SUI)
The SUI measures strategy use in daily life with two subscales. The subscale External Strategies consists of 6 items and includes the use of memory aids, such as taking notes or using a calendar. The subscale Internal Strategies consists of 8 items and includes mnemonics such as mental rehearsal or creating associations. Participants indicate how often they use a certain strategy by rating items on a 5-point Likert scale. Average item scores were calculated for each subscale (external strategies range 0-30, internal strategies range 0-40, higher score meaning more strategies used).
Measured: 4 measurements during study participation (during 13 weeks)
Adapted Illness Cognition Questionnaire (ICL)
The ICL measures illness cognitions that are assumed to be an important mediator between disease and patients' well-being . The two subscales 'helplessness' and 'acceptance' each consist of 6 items. No total score can be computed, average item scores were calculated for each subscale (range 0-24, higher scores reflecting more experienced helplessness (subscale 1) and more acceptance (subscale 2)). The questionnaire will be adapted so that it can be used to measure cognitions regarding 'memory complaints' instead of cognitions regarding illness in general
Measured: 4 measurements during study participation (during 13 weeks)
Measure of feasibility by patients and practitioners 1: qualitative questionnaire
The subjective effectiveness and feasibility of the whole Karman Line memory strategy training intervention will be measured by a qualitative questionnaire that is completed by the therapist and patient after the intervention.
Measured: 1 measurement during study participation (during 13 weeks)
Measure of feasibility by patients and practitioners 2: the System User Scale
The questionnaire consists of 10 items, rated on a 5-point scale (range 0-50, higher score meaning better game user expercience)
Measured: 1 measurement during study participation (during 13 weeks)
Measure of feasibility by patients 3: time spent playing the game
Time spent on playing the different levels of the game and mistakes that are made while playing, which will be monitored automatically.
Measured: during study participation (during 13 weeks)
Measure of feasibility by patients 4: number of dropouts and no shows
- The number of, and reasons for, dropouts during the intervention
- The number of, and reasons for, no-shows of the face-to-face sessions
Measured: during study participation (during 13 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start21 Jan 2025
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain Injury (Including Stroke)Studies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klimmendaal Revalidatiespecialisten
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774287
- Sponsor's protocol ID
- KNP23PROJ1
- Status last verified
- Nov 2025
- First submitted
- 25 Sep 2024
- Last updated
- 22 May 2026
- 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Karman Line Memory Strategy Training, a Combined Computerized and Face-to-face Compensatory Treatment Targeting Memory Complaints After Acquired Brain Injury, Using Single-case Experimental Design Methodology
- ClinicalTrials.gov ID
- NCT06774287
- Acronym / sponsor ID
- KNP23PROJ1
- Conditions
- Acquired Brain Injury (Including Stroke)
- Keywords
- Compensatory brain games, Acquired Brain Injury, memory disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Klimmendaal RevalidatiespecialistenResearch network
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 14 Jan 2025 (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.
Rationale: Acquired brain injury (ABI) often results in memory deficits that can have a big impact on social and vocational functioning of patients. Rehabilitation treatment of memory dysfunction consists of optimizing memory performance by using effective compensation strategies. Several effective memory-strategy training programs have been developed. However, these often contain labor-intensive treatment protocols that are possibly an overtreatment of ABI patients with relatively mild memory impairments. On the other hand there is a sprawl of commercial computerized cognitive training programs or 'brain games' available that claim to restore memory function. However, research has repeatedly shown that treatment effects of available brain games do not generalize to daily life functioning. With the shortcomings of current memory treatment programs in mind, the investigators developed a combined computerized and face-to-face training of memory strategies, which consists of a shortened traditional face-to-face treatment combined with an innovative Brain Game based on compensation strategies instead of restorative training. This is a promising cost-effective intervention that provides the possibility of repeated practice at home to train compensatory strategies in a safe and imaginative digital environment. The hypothesis is the strategy training will promote generalization, also after rehabilitation ends.
Objective: The primary objective is the evaluation of the potential positive effect of the combined computerized and face-to-face memory treatment on effective memory strategy use and reducing subjective memory failures in ABI patients with memory deficits in the chronic phase of acquired brain injury (>3 months after injury).
Study design: The study will be a multiple-baseline across individuals single-case experimental design (SCED). Three patients will receive treatment as usual and three patients will receive a shortened treatment combined with the game, which will be referred to as the 'Karman Line memory strategy training'.
Study population: The study population consists of patients referred for outpatient cognitive rehabilitation. Participants eligible for the study must have memory deficits and complaints due to Acquired Brain Injury (ABI) of nonprogressive nature (i.e. TBI, stroke), with a minimum time post-onset of 3 months. Age has to be between 18 and 75 and participants have to live independently at home. Memory deficits will be assessed by neuropsychological examination, memory complaints will be assessed by the Everyday Memory Questionnaire-Revised (EMQ-R). In one year six to eight participants will be recruited.
Intervention: The Karman Line memory strategy training consists of six weekly treatment sessions under the guidance of a therapist. The protocol is a shortened version of an existing memory strategy training (treatment as usual), which contains ten sessions. In the sessions, patients get information about memory and memory strategies and learn to apply those to their personal treatment goals. Inbetween the sessions, the participant will work on personal memory goals and practice the strategies by playing the corresponding levels of the memory game at home.
Main study parameters/endpoints: The main study parameter is the three most commonly reported memory complaints selected from the 13-item scale of the EMQ-R. The primary outcome measure is not the EMQ-R, but a personalized set of measurement VAS-scales for each patient. Secondary study parameters include the impact of memory problems on activities and participation, the achievement of personalized treatment goals, objective strategy use, objective memory functioning, metacognitions about memory and measures of feasibility by patients and practitioners.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden in the study consists of participating in repeated measurements, therapy sessions, and homework assignments. All tests and methods that are used are non-invasive and not stressful for the patient. All tests and tasks will be based on widely-used validated and reliable paper-pencil or computer tasks. Treatment is non-invasive and scarcely stressful: a therapist will always be present and assess the patient's burden and eventually take appropriate measures such as inserting a resting break.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment as usual | Active comparator | Behavioral: Treatment as usualTreatment as usual contains 10 memory strategy sessions (two sessions per week) with a therapist in the rehabilitation centre. |
| Karman Line memory training | Experimental | Behavioral: Karman Line memory strategy trainingKarman Line memory strategy training contains 6 weekly memory strategy sessions in the rehabilitation centre, combined with practicing digital games at home and using a memory app. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- presence of subjective memory complaints. Memory complaints will be operationalized as ≥1 standard deviation on the total score of the EMQ-R questionnaire in comparison with the healthy control norm.
- presence of mild to moderate objective memory deficits, objectified with neuropsychological assessment for clinical purposes. Mild to moderate memory deficits will be operationalized as test score ≥1 standard deviation (SD) and <2 SD in comparison to the normative mean on at least two separate memory measures and no more than one measure ≥ 2SD. For each task the norm data that is described in the test manual will be used.
- Age: 18-75 years
- Non-progressive acquired brain injury
- Minimal time post-onset of 3 months
Key exclusion criteria (12 listed)
- Severe memory deficits
- Inability to speak and/or understand the Dutch language
- Severe disorders in executive functioning
- Severe psychiatric problems
- Neurodegenerative disorders
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 |
|---|---|---|
| Karman Line memory strategy trainingThe memory strategy training consists of six weekly face-to-face treatment sessions. After sessions 3-5, the participant will play 8 levels in total of the Karman Line memory game on their computer or mobile device. In these levels they practice the strategies that are introduced in the face-to-face treatment in a safe digital environment. Also, the Karman Line memory app is provided. | Behavioural | Karman Line memory training |
| Treatment as usualTreatment as usual contains ten sessions, with nine obligatory sessions supplemented with 1 (of five) non-obligatory sessions. Which non-obligatory sessions is chosen is dependent on the patients treatment goals. | Behavioural | treatment as usual |
Primary outcome
memory complaints
Time frame: every other day during 8-10 weeks, weekly during 3-5 weeks
The 13-item scale of the everyday memory questionnaire-revised (EMQ-R) is used to select the three most common memory complaints that are targeted with the intervention. The primary outcome measure is not the EMQ-R, but a personalized set of measurement visual analogue scales (VAS) for each patient. The total score (range 0-30) will be used as outcome measure. A higher score indicates more memory complaints, which is a worse outcome.
16 secondary outcomes
The impact of memory problems on activities and participation
Time frame: every other day during 8-10 weeks, weekly during 3-5 weeks
The achievement of personalized treatment goals
Time frame: 4 measurements during study participation (during 13 weeks)
Objective strategy use task
Time frame: 4 measurements during study participation (during 13 weeks)
Rivermead Behavioural Memory Test-3 (RBMT-3-NL)
Time frame: 2 measurements during study participation (during 13 weeks)
Location Learning Test (LLT)
Time frame: 2 measurements during study participation (during 13 weeks)
Verbal learning and memory test (VLGT).
Time frame: 2 measurements during study participation (during 13 weeks)
Delis-Kaplan Executive Function System Color Word Interference Test (D-KEFS CWIT)
Time frame: 2 measurements during study participation (during 13 weeks)
Wechsler Memory Scale IV-NL Symbol span
Time frame: 2 measurements during study participation (during 13 weeks)
Wechsler Adult Intelligence Scale IV-NL digit span (WAIS-IV-NL DS)
Time frame: 2 measurements during study participation (during 13 weeks)
Cognitive Failure Questionnaire (CFQ)
Time frame: 4 measurements during study participation (during 13 weeks)
Strategy Use in daily life Inventory (SUI)
Time frame: 4 measurements during study participation (during 13 weeks)
Adapted Illness Cognition Questionnaire (ICL)
Time frame: 4 measurements during study participation (during 13 weeks)
Measure of feasibility by patients and practitioners 1: qualitative questionnaire
Time frame: 1 measurement during study participation (during 13 weeks)
Measure of feasibility by patients and practitioners 2: the System User Scale
Time frame: 1 measurement during study participation (during 13 weeks)
Measure of feasibility by patients 3: time spent playing the game
Time frame: during study participation (during 13 weeks)
Measure of feasibility by patients 4: number of dropouts and no shows
Time frame: during study participation (during 13 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Karman Line memory strategy training and Treatment as usual in people with Acquired Brain Injury (Including Stroke), run by Klimmendaal Revalidatiespecialisten at 1 site in Netherlands.
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 8 inclusion and 12 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: finished, as of the sponsor's last update on 22 May 2026. 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 Netherlands. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
memory complaints (time frame: every other day during 8-10 weeks, weekly during 3-5 weeks). 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 22 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.