SYNAPSE-FTLD

Developing treatment for challenging behaviours in frontotemporal dementia and related disorders.

Officially registered as SYNAPSE-FTLD: Design and delivery of clinical trials to treat challenging behaviours in the syndromes associated with frontotemporal lobar degeneration.

Research summary

Frontotemporal dementia, primary progressive aphasia, progressive supranuclear palsy and corticobasal syndrome are incurable brain diseases. These illnesses have different root causes but have much in common in their distressing symptoms. Behavioural change, impulsivity, personality change, apathy, and obsessional habits occur in some, but not all, participants with each of these illnesses. Our research suggests that a lack of serotonin contributes to these challenging behaviours. We propose a clinical trial that will test a widely-used drug that increases serotonin levels, citalopram, compared to a dummy tablet (called a placebo). Results could quickly be translated into clinical practice. In the longer term, our project will strengthen the UK expertise for clinical trials in the frontotemporal dementia and related disorders, moving us closer to effective treatments for these devastating conditions.

Main inclusion criteria

  • Aged 18 years or over
  • A clinical diagnosis according to current consensus clinical diagnostic criteria of either probable or definite bvFTD (with or without motor neuron disease), nfvPPA, svPPA, probable PSP (any subtype) or probable CBS.

  • Challenging behavioural impairment, defined as either or both:

    -  Subjectively by the patient, informant or clinician as having a clinically-significant impairment on quality of life

    -  Objectively as a CBI-Behaviour score greater than 10

  • An adult informant (relative, friend, unpaid or paid carer or care home staff) who has at least weekly contact and consents to complete informant 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
  • Current or recent (<4 weeks) use of a medication known to interact with citalopram (see section 9.3 for list)
  • Known QT-internal prolongation or congenital long QT syndrome
  • High clinical suspicion of Alzheimer's disease (AD), as defined either by the positive AD biomarkers (CSF or PET) or if clinical presentation is more consistent with a diagnosis of an AD variant (e.g. PCA rather than CBS, or the IvPPA language presentation of AD rather than nfvPPA or svPPA)
  • Pregnant, breastfeeding or planning to become pregnant during the trial
  • Presence of significant neurological (other than FTLD-related) or psychiatric disorders including active suicidal ideation that are by the PI to represent a current safety risk
  • Presence or history of any condition that the PI feels may interfere with the participant's ability to comply with study instructions, would place the participant at increased risk, or might confound the interpretation of the study results.

Chief investigator

Dr Alexander Murley

Contact details

Clinical Trials Coordinator: Kerry Dresser

Email: [email protected]