SYNAPSE-FTLD

A trial to test the efficacy of citalopram in frontotemporal lobar degeneration-related syndromes

 

Research summary

Frontotemporal dementia (FTD), semantic primary progressive aphasia (svPPA, also known as semantic dementia), progressive supranuclear palsy (PSP) and corticobasal syndrome (CBS) are all caused by the brain disease frontotemporal lobar degeneration (FTLD). These illnesses also have much in common, including some symptoms like impulsivity, personality change, apathy, and obsessional habits. These challenging behaviours have no proven effective treatments, cause considerable distress to individuals and their families, and are associated with a poor prognosis. Recent research suggests that low levels of a brain chemical called serotonin is associated with these symptoms. This trial will test if citalopram, which increases serotonin transmission in the brain, is an effective treatment. 

Main inclusion criteria

  • Aged 18 years or over, of any sex and gender.
  • A clinical diagnosis according to current consensus clinical diagnostic criteria of either possible, probable or definite behavioural variant frontotemporal dementia (bvFTD) (with or without motor neuron disease), semantic variants of primary progressive aphasia (svPPA), probable progressive supranuclear palsy (PSP) (any subtype) or probable corticobasal syndrome (CBS).
  • Challenging behavioural impairment, defined as either or both:
  1. Subjectively by the patient, companion or clinician as having a clinically-significant impairment on quality of life.
  2. Objectively as a CBI-Behaviour score greater than 10.
  • Be a fluent English speaker prior to their FTLD-related illness.
  • Have a companion (relative, friend, unpaid or paid carer or care home staff) who has at least weekly contact, is a fluent English speaker and consents to complete companion questionnaires. 

Main exclusion criteria

  • Hypersensitivity to citalopram or to any of the excipients.
  • Current or recent (<2 weeks) use of a selective-serotonin reuptake inhibitor (SSRI).
  • Current or recent use of other significantly serotonergic agents, such as triptans, oxitriptan opioids (incl. buprenorphine and tramadol) and tryptophan.
  • Current or recent (<4 weeks) use of a medication known to significantly interact with citalopram.
  • Known QT-interval prolongation or congenital long QT syndrome.
  • High clinical suspicion of AD, as defined either by the positive AD biomarkers or if clinical presentation is more consistent with a diagnosis of an AD variant.
  • Pregnant, breastfeeding or planning to become pregnant during the trial.
  • Presence of significant neurological (other than FTLD-related) or psychiatric disorders including suicidal ideation that are believed by the PI to represent a current safety risk.
  • Currently enrolled in other clinical trial testing an unlicenced medication or have received an unlicenced medication in a clinical trial within 4 weeks of the Screening Visit.
  • Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to trial requirements. 

Chief investigator

Dr Alexander Murley

Contact details

Clinical Trials Coordinator: Meisha Davies, Kerry Dresser

Email: [email protected]