Efficacy and Safety of Oral Midazolam Used for the Delivery of Care in Elderly Patient With Neurocognitive Disorders and Refusing Care.

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity Hospital, Grenoble

About this trial

The purpose of this study is to assess the effectiveness of oral midazolam on the delivery of care in elderly patients with moderat to severe neurocognitive disorders and opposing care.

Eligibility criteria

Qualifiers

Patient hospitalized (for a minimum estimated duration of 21 days) in a geriatric department in Medical Care and Rehabilitation, Cognitive-Behavioral Unit, or housed in a Reinforced Housing Unit, in a Long-Term Care Unit, or in a Psycho-Geriatric Unit.

Moderate to severe cognitive impairment, defined by a MMSE (Mini Mental State Examination) score <15. If not feasible at inclusion, MMSE score <15 less than 1 year old.

Patient opposed to care, presenting at least two episodes of opposition to care (meals excluded) for which other non-medication alternatives have failed. These refusals of care are defined by a "resistance to care" score ≥3 on the Pittsburgh scale, over the last week. In practice, the resistance to care of patients is noted in the medical record following a weekly multidisciplinary decision.

Person affiliated with social security or beneficiary of such a scheme

Disqualifiers

Patient who has received midazolam treatment in the week before inclusion

Known hypersensitivity to the active substance, benzodiazepines, or any of the excipients

Weight <50 kg and >100 kg

Gastrointestinal pathology that may limit or prevent the absorption of midazolam

Trial design

Treatments tested in this trial

  • oral administration of midazolam or placebo

Treatment groups

30 Participants
are divided into 2 treatment groups

Locations

1
Geriatric department of Grenoble Alpes university hospital38043, GrenobleIsere, France

Sponsors and collaborators

University Hospital, Grenoble

Lead sponsor