RHAPSODY

RHAPSODY pilot study

UK Chief Investigator

Allan Young

Research summary

A study to investigate the feasibility of administration of a speech battery and the use of speech-based biomarkers for the clinical assessment of common neurodegenerative and psychiatric disorders in a remote setting.

Inclusion / exclusion criteria

Inclusion criteria

  • Willing to participate, having been provided full information about the study components and details.

  • Native language is English.

  • Capacity to provide fully informed consent.

  • Access to and able to use, or has a caregiver who has access to and able to use a smartphone device running an operation system of iOS 10.1 or later, or Android 9.0 or later.

  • Able to use, or has a caregiver who is able to use a personal computer, notebook or tablet.

  • Access to a personal computer, notebook or tablet that is running an operating system of: macOS X with macOS 10.9 or later, or Windows 7 or above.

  • Capable of audio and video recording.

  • Able to connect to the internet.

  • Access to one of following internet browsers: Internet Explorer version 11 or above, or Microsoft Edge version 12 or above, or Firefox version 27 or above, or Google Chrome version 30 or above, or Safari version 7 or above.

Group 1: Cognitive disorders

Alzheimer's disease

Meet the National Institute of Aging – Alzheimer's Association (NIA-AA) core clinical criteria (2011) for MCI due to Alzheimer's or mild Alzheimer's.

Dementia

  • Date of diagnosis not more than five years prior to consent.

  • Subjects must have MMSE72 scores of 23–30 (inclusive), or TICS4073 score of 20–40 (inclusive) based on a test not older than one month at the time of consent.

  • Age of 50–85 years (inclusive).

Dementia with Lewy bodies (DLB)

  • Diagnosis of possible or probable DLB based on the criteria defined by The Dementia with Lewy Bodies Consortium (2015).

  • Date of diagnosis not more than five years prior to consent.

  • Subjects must have MMSE72 scores of 23–30 (inclusive), or TICS4073 score of 20–40 (inclusive) based on a test not older than one month at the time of consent.

  • Age of 50–85 years (inclusive).

Non-AD non-DLB MCI

  • Diagnosis of 'probable' and 'possible' bvFTD according to the International Behavioral Variant FTD Criteria Consortium, or diagnosis of svPPA FTD or nfaPPA FTD (aphasia) according to Mesulam's criteria, or clinical diagnosis of vascular dementia according to NINDS‐AIREN International Workshop.

  • MMSE score of 23–30 (inclusive) or TICS40 score of 20-40 (inclusive) on a test not older than one month at the time of consent.

  • Age of 50–85 years (inclusive).

  • Not eligible under Alzheimer's disease or dementia with Lewy bodies criteria.

Group 2: Motor disorders

Parkinson's disease

  • Diagnosis of idiopathic Parkinson's disease based on the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria.

  • Date of diagnosis not more than five years prior to consent.

  • Hoehn and Yahr stage 2 or less.

  • Age of 30–85 years (inclusive).

Motor neuron disease

  • Diagnosis of amyotrophic lateral sclerosis based on gold-standard clinical criteria.

  • Stage 3 or less on the King's ALS Staging system

  • Age of 18–85 years (inclusive).

Group 3: Affective disorders

Major depressive disorder

  • Meet DSM-5 criteria for a current major depressive episode (MDE) as assessed by the MINI.

  • Current episode of at least moderate severity as assessed by the Clinical Global Impression (CGI) scale.

  • Date of diagnosis (using MINI assessment) and severity (CGI) maximum of two months prior to consent.

  • Age of 18–85 years (inclusive).

Bipolar disorder

  • Meet DSM-5 criteria for BD as assessed by the MINI (type 1 or type 2).

  • Current depressive episode as assessed by the MINI Current episode of at least moderate severity as assessed by the Clinical Global Impression (CGI) scale.

  • Date of diagnosis (using MINI assessment) and severity (CGI) maximum of two months prior to consent.

  • Age of 18–85 years (inclusive).

Group 4: Unaffected controls

  • Control participants will be recruited in three separate groups:

    • One approximately matched to the 'Group 1: Cognitive disorders' cohort in terms of gender, age and education levels.

    • One approximately matched for 'Group 2: Motor disorders'.

    • One approximately matched for the 'Group 3: Affective disorders' cohort.

  • The target number for recruitment is 25-25 HC participants in each group.

Group 4 specific recruitment criteria matched for the 'Group 1: Cognitive disorders' cohort:

    • Age of 50–85 years (inclusive).

    • Approximately age, gender and education matched to AD subjects on a group level. In otherwise good health condition, or with diagnosis mild chronic disorders (of metabolic, respiratory, immunological, cardiologic, and metabolic origin) or any other affections that are controlled by the therapy and do not importantly limit ADLs or social interactions.

    • Recruited at or referred from the same site as 'Group 1: Cognitive disorders' participants.

Group 4 specific recruitment criteria matched for the 'Group 2: Motor disorders' cohort:

    • Age of 30–85 years (inclusive).

    • Approximately age, gender and education matched to PD subjects on a group level.

    • In otherwise good health condition, or with diagnosis mild chronic disorders (of metabolic, respiratory, immunological, cardiologic, and metabolic origin) or any other affections that are controlled by the therapy and do not importantly limit ADLs or social interactions.

    • Recruited at or referred from the same site as 'Group 2: Motor disorders' participants.

Group 4 specific recruitment criteria matched for the 'Group 3: Affective disorders' cohort:

    • Age of 30–85 years (inclusive).

    • Approximately age, gender and education matched to MDD/BD subjects on a group level.

    • In otherwise good health condition, or with diagnosis mild chronic disorders (of metabolic, respiratory, immunological, cardiologic, and metabolic origin) or any other affections that are controlled by the therapy and do not importantly limit ADLs or social interactions.

    • Recruited at or referred from the same site as 'Group 3: Affective disorders' participants.

Exclusion criteria

  • Diagnosis of alcohol or drug use disorder.

  • History or presence of stroke within the past two years.

  • Documented history of transient ischemic attack or unexplained loss of consciousness within the last 12 months.

  • At risk of suicide in the opinion if the investigator.

Current status

Active – recruiting

Locations

  • Maudsley Hospital

  • King's College Hospital, London

Information about study sites

Contact details

Marton Meszaros

Email: marton@novoic.com

Recruitment group(s)

Mental and behavioural disorders

  • Mood (affective) disorders

  • Organic, including symptomatic, mental disorders

Diseases of the nervous system

  • Other degenerative diseases of the nervous system

  • Extrapyramidal and movement disorders

  • Systemic atrophies primarily affecting the central nervous system

Recruitment target(s)

225 study participants

Key dates

Actual opening date: 21 July 2021

Recruitment planned end date: 30 June 2022

Funder(s)

NOVOIC Ltd

Sponsor

NOVOIC Ltd

Study design

Observational

Intervention (if applicable)

Not applicable

Phase (if applicable)

Not applicable

Publications / Results reports

Links will be provided when papers are published.