Huntington DiseaseNCT07253038
Evaluation of Three Tests to Assess Social Cognition in Huntington Disease
An observational study of Huntington Disease, run by Region Skane at 1 site in Sweden.
Trial summary
The goal of this observational study is to learn about the usefulness of a test of social functioning in persons with Huntington disease. Huntington disease affects motor function, psychological well-being and cognitive functions ("thinking abilities" such as paying attention, remembering and solving problems). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Huntington Disease
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2025to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recruitment of participants will be made at the HD clinic in Lund, Sweden and through ethical review board-approved advertisment material posted at social media platforms and websites hosted by the Huntingtoncenter at Lund and the Swedish patient organization Riksförbundet för Huntingtons sjukdom (RHS) as well as YTAN.
Who may be able to join
- Clinical diagnosis of HD
- CAG repeat: 40 and more
- 1. No heritage of HD or negative pre-symptomatic HD gene test
Who cannot join
- Participants in both groups are excluded from the study if any of the following criteria apply:
- Dementia or MOCA<19, The Mini Mental State Examination (MMSE) <19
- Other neurological disorders
- Ongoing psychosis
- Ongoing alcohol/drug addiction
- Other native language than Swedish
- Severe problems with vision and hearing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Skane University Hospital, Region Skane
Lund, 22184
Isak Halling, MSc, +4646178188, isak.halling@skane.se
Asa Petersen, MD, PhD, +46462221686, asa.petersen@med.lu.se
About this study
Official title: The Social-HD Study: A Cross-Sectional Observational Study of Social Cognition in Early Huntington Disease
The goal of this observational study is to learn about the usefulness of a test of social functioning in persons with Huntington disease. Huntington disease affects motor function, psychological well-being and cognitive functions ("thinking abilities" such as paying attention, remembering and solving problems). It is also believed to affect important social functions, including the ability to understand others' intentions and emotions (social cognition). The test of interest in this study is called The Double Movie for the Assessment of Social Cognition-Multiple Choice (DMASC-MC) and will be compared to two other similar and well-known tests. The main question which the study aims to answer is:
- Is DMASC-MC a useful tool for detecting problems with social functioning in adult persons with early Huntington disease? In the study, participants will meet with a medical doctor and a psychologist for assessment of different symptoms related to Huntington disease, including social functioning. Better methods for identifying problems with social functioning could help persons with Huntington disease and their families in mainly two ways. Firstly, it could increase their understanding of how the disease has affected them. Secondly, a better understanding of these problems could lead to better recommendations and interventions from medical teams, which would also benefit persons with Huntington disease and families.
Read the detailed description
Background:
Huntington disease (HD) is a fatal neurodegenerative disorder that leads to motor disturbances, psychiatric symptoms and dementia. It is caused by an expanded CAG repeat in the huntingtin (HTT) gene which is inherited in an autosomal dominant fashion with full penetrance. It typically manifests in midlife. There are no disease-modifying therapies and current care is focused on reducing symptoms and improving quality of life. An important understudied part of the clinical manifestation is the early development of personality changes that have major impact on most aspects of the life of the affected person. These changes may be due to altered social cognition. Today, assessment of social cognition is often not part of the neuropsychological battery for HD and the so far investigated tests may not capture sufficient aspects of altered social cognition.
Aim:
The aim is to investigate whether the social cognitive test "Double Movie for the Assessment of Social Cognition-Multiple Choice (DMASC-MC) " will detect a significant difference in persons with early stages of HD compared to age and sex matched controls.
Methods:
This clinical research study will include 20 persons with early HD and 20 matched controls. The number of participants is based on a power calculation. The research participants will be assessed using DMASC-MC as well as two other tests for social cognition, Reading the Mind in the Eyes Test and The Emotion Hexagon Test. They will also be evaluated for typical cognitive deficits, psychiatric symptoms and motor aspects in HD.
Relevance:
This study aims to bridge an important gap in clinical care where evaluation of social cognition is not yet part of standard assessments. Determination of social cognitive deficits will be important for planning care and facilitate communication for HD families.
- Conditions
- Huntington Disease
- Keywords
- social cognition, apathy, cognition, depression, total functional capacity, total motor score
- Medical subject headings
- Huntington Disease, Lethargy, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Huntington disease | Participants with early Huntington disease | |
| Controls | Participants with no heritage of HD or negative pre-symptomatic HD gene test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant difference in mean value of "Double Movie for the Assessment of Social Cognition-Multiple Choice" (DMASC-MC) total score between HD and controls
To investigate if persons with HD have a significantly lower score than a control group in the test "Double Movie for the Assessment of Social Cognition-Multiple Choice" (DMASC-MC)". DMASC-MC: Minimum value 0, maximum value 44, higher scores mean a better outcome.
Measured: Baseline
Secondary outcomes (10)
Significant difference in mean value of Reading the Mind in the Eyes Test (RMET) total score between HD and controls
To investigate if persons with HD have a significantly lower score than a control group in the Reading the Mind in the Eyes Test (RMET) test. RMET: Minimum value 0, maximum value 36, higher scores mean a better outcome.
Measured: Baseline
Significant difference in mean value of Emotional Hexagon Test (EHT) total score between HD and controls
To evaluate if persons with HD have a significantly lower score than a control group in the Emotional Hexagon Test (EHT). EHT: Minimum value 0, maximum value 24, higher scores mean a better outcome.
Measured: Baseline
Significant correlation between social cognitive test scores and Montreal Cognitive Assessment (MOCA) scores
To investigate if there is a correlation between social cognitive test scores and Montreal Cognitive Assessment (MOCA scores = cognitive scores). MOCA scale: Minimum value 0, maximum value 30 points, lower scores mean a worse outcome.
Measured: Baseline
Significant correlation between social cognitive test scores and total functional capacity (TFC) scores
To investigate if there is a correlation between social cognitive test scores and total functional capacity (TFC scores =scores for everyday life function in HD). TFC: Minimum value 0, maximum value 13, higher scores mean a better outcome.
Measured: Baseline
Significant correlation between social cognitive test scores and CAG-Age-Product (CAP) scores
To investigate if there is a correlation between social cognitive test scores and CAG-Age-Product (CAP scores =scores for disease burden).CAP scores are calculated as the product of the length of the expanded CAG repeat and age, indicating a cumulative burden that predicts progression of HD. Higher CAP product means larger disease burden.
Measured: Baseline
Significant correlation between social cognitive test scores and total motor scores (TMS).
To investigate if there is a correlation between social cognitive test scores and total motor scores (TMS = motor scores). TMS: minimum value 0, maximum value 124, lower scores mean a better outcome.
Measured: Baseline
Significant correlation between social cognitive test scores and Montgomery-Åsberg Depression Rating Scale (MADRS) scores
To investigate if there is a correlation between social cognitive test scores and Montgomery-Åsberg Depression Rating Scale (MADRS) scores (= depression scores). MADRS: Minimum value 0, maximum value 60, lower scores mean a better outcome.
Measured: Baseline
Significant correlation between social cognitive test scores and apathy evaluation scale (AES) scores
To investigate if there is a correlation between social cognitive test scores and apathy evaluation scale (AES) scores (= apathy scores). AES: Minimum value 18, maximum value 72, lower scores mean a better outcome.
Measured: Baseline
Significant correlation between social cognitive test scores and cognitive scores
To investigate if there is a correlation between social cognitive test scores and Symbol digit modalities test (SDMT)/D-KEFS Color Word Interference Test (CWIT)/ D-KEFS Verbal Fluency Test (VFT) scores (= cognitive scores). SDMT: Minimum value 0, maximum value 110, higher scores mean a better outcome.
CWIT: no minimum value, maximum value 180, lower scores mean a better outcome. VFT: Minimum value 0, no maximum value, higher scores mean a better outcome.
Measured: Baseline
Proportion of both HD subjects and control subjects with impaired results on each of the social cognitive tests, compared to norms.
Percentage of subjects within the HD group performing below 1,5 SD compared to norm data on DMASC-MC, RMET and EHT, compared to prior norm data. Percentage of subjects within the control group performing below 1,5 SD compared to norm data on DMASC-MC, RMET and EHT.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start1 Dec 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asa Petersen, MD PhD, Principal investigator, Department of Psychiatry, Skåne University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253038
- Sponsor's protocol ID
- 2025-04424-01
- Other IDs
- 2025
- Status last verified
- Mar 2026
- First submitted
- 17 Nov 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Social-HD Study: A Cross-Sectional Observational Study of Social Cognition in Early Huntington Disease
- ClinicalTrials.gov ID
- NCT07253038
- Acronym / sponsor ID
- 2025-04424-01
- Conditions
- Huntington Disease
- Keywords
- social cognition, apathy, cognition, depression, total functional capacity, total motor score
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 28 Nov 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.
The goal of this observational study is to learn about the usefulness of a test of social functioning in persons with Huntington disease. Huntington disease affects motor function, psychological well-being and cognitive functions ("thinking abilities" such as paying attention, remembering and solving problems). It is also believed to affect important social functions, including the ability to understand others' intentions and emotions (social cognition). The test of interest in this study is called The Double Movie for the Assessment of Social Cognition-Multiple Choice (DMASC-MC) and will be compared to two other similar and well-known tests. The main question which the study aims to answer is:
- Is DMASC-MC a useful tool for detecting problems with social functioning in adult persons with early Huntington disease? In the study, participants will meet with a medical doctor and a psychologist for assessment of different symptoms related to Huntington disease, including social functioning. Better methods for identifying problems with social functioning could help persons with Huntington disease and their families in mainly two ways. Firstly, it could increase their understanding of how the disease has affected them. Secondly, a better understanding of these problems could lead to better recommendations and interventions from medical teams, which would also benefit persons with Huntington disease and families.
Detailed description
Background:
Huntington disease (HD) is a fatal neurodegenerative disorder that leads to motor disturbances, psychiatric symptoms and dementia. It is caused by an expanded CAG repeat in the huntingtin (HTT) gene which is inherited in an autosomal dominant fashion with full penetrance. It typically manifests in midlife. There are no disease-modifying therapies and current care is focused on reducing symptoms and improving quality of life. An important understudied part of the clinical manifestation is the early development of personality changes that have major impact on most aspects of the life of the affected person. These changes may be due to altered social cognition. Today, assessment of social cognition is often not part of the neuropsychological battery for HD and the so far investigated tests may not capture sufficient aspects of altered social cognition.
Aim:
The aim is to investigate whether the social cognitive test "Double Movie for the Assessment of Social Cognition-Multiple Choice (DMASC-MC) " will detect a significant difference in persons with early stages of HD compared to age and sex matched controls.
Methods:
This clinical research study will include 20 persons with early HD and 20 matched controls. The number of participants is based on a power calculation. The research participants will be assessed using DMASC-MC as well as two other tests for social cognition, Reading the Mind in the Eyes Test and The Emotion Hexagon Test. They will also be evaluated for typical cognitive deficits, psychiatric symptoms and motor aspects in HD.
Relevance:
This study aims to bridge an important gap in clinical care where evaluation of social cognition is not yet part of standard assessments. Determination of social cognitive deficits will be important for planning care and facilitate communication for HD families.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Huntington disease | – | –Participants with early Huntington disease |
| Controls | – | –Participants with no heritage of HD or negative pre-symptomatic HD gene test |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment of participants will be made at the HD clinic in Lund, Sweden and through ethical review board-approved advertisment material posted at social media platforms and websites hosted by the Huntingtoncenter at Lund and the Swedish patient organization Riksförbundet för Huntingtons sjukdom (RHS) as well as YTAN.
Key inclusion criteria (3 listed)
- Clinical diagnosis of HD
- CAG repeat: 40 and more
- 1. No heritage of HD or negative pre-symptomatic HD gene test
Key exclusion criteria (7 listed)
- Participants in both groups are excluded from the study if any of the following criteria apply:
- Dementia or MOCA<19, The Mini Mental State Examination (MMSE) <19
- Other neurological disorders
- Ongoing psychosis
- Ongoing alcohol/drug addiction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Significant difference in mean value of "Double Movie for the Assessment of Social Cognition-Multiple Choice" (DMASC-MC) total score between HD and controls
Time frame: Baseline
To investigate if persons with HD have a significantly lower score than a control group in the test "Double Movie for the Assessment of Social Cognition-Multiple Choice" (DMASC-MC)". DMASC-MC: Minimum value 0, maximum value 44, higher scores mean a better outcome.
10 secondary outcomes
Significant difference in mean value of Reading the Mind in the Eyes Test (RMET) total score between HD and controls
Time frame: Baseline
Significant difference in mean value of Emotional Hexagon Test (EHT) total score between HD and controls
Time frame: Baseline
Significant correlation between social cognitive test scores and Montreal Cognitive Assessment (MOCA) scores
Time frame: Baseline
Significant correlation between social cognitive test scores and total functional capacity (TFC) scores
Time frame: Baseline
Significant correlation between social cognitive test scores and CAG-Age-Product (CAP) scores
Time frame: Baseline
Significant correlation between social cognitive test scores and total motor scores (TMS).
Time frame: Baseline
Significant correlation between social cognitive test scores and Montgomery-Åsberg Depression Rating Scale (MADRS) scores
Time frame: Baseline
Significant correlation between social cognitive test scores and apathy evaluation scale (AES) scores
Time frame: Baseline
Significant correlation between social cognitive test scores and cognitive scores
Time frame: Baseline
Proportion of both HD subjects and control subjects with impaired results on each of the social cognitive tests, compared to norms.
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Home page for the Huntington Disease Center at Region SkateLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Asa Petersen, MD PhD principal investigator
Department of Psychiatry, Skåne University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Huntington Disease, run by Region Skane at 1 site in Sweden.
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 3 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: looking for participants now, as of the sponsor's last update on 11 Mar 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asa Petersen, MD, PhD (+46462221686, asa.petersen@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant difference in mean value of "Double Movie for the Assessment of Social Cognition-Multiple Choice" (DMASC-MC) total score between HD and controls (time frame: Baseline). 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 11 Mar 2026.