RHAPSODY

Study titleRHAPSODY Pilot Study
UK Chief Investigator
Research summaryA 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 criteriaINCLUSION CRITERIA

Willing to participate, having been provided full information about the study components and details. Native language is English. Has the capacity to provide fully informed consent. Has 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. Has access to a personal computer, notebook or tablet of that is: Running an operating system of: macOS X with macOS 10.9 or later; or Windows 7 or above; or Capable of audio and video recording. Able to connect to the internet. Have access to one of following internet browser software 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 1 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)74 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 1 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 criteria75 OR Clinical Diagnosis of Vascular Dementia according to NINDS‐AIREN International Workshop76 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 stage77 2 or less Age of 30-85 years (inclusive) Motor neuron Disease Diagnosis of Amyotrophic Lateral Sclerosis based on gold-standard clinical criteria78 Stage 3 or less on the King’s ALS Staging system79 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 the ‘Group 2: Motor disorders’ and 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

General subject exclusion criteria: Diagnosis of alcohol or drug use disorder; History or presence of stroke within the past 2 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 statusActive – recruiting
LocationsMaudsley Hospital
King’s College Hospital, London
Contact detailsMarton Meszaros - 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)250 study participants.
Key datesActual opening date: 21 July 2021
Recruitment planned end date: 01 November 2021
Funder(s)NOVOIC Ltd
SponsorNOVOIC Ltd
Study designObservational
Intervention (if applicable)Not applicable
Phase (if applicable)Not applicable
Outcome measures
Publications / Results reportsLinks will be provided when papers are published.
Participant Information Sheet