NCT04614532: DOMASNA

Recognizing Pain Intensity in Alzheimer's Disease

Terminated NA Last updated 15 October 2024

What this trial tests

NA trial testing cognitive assessment in Alzheimer Disease in 28 participants. Terminated before completion.

Timeline

24 November 2021

Primary endpoint
6 April 2023

6 April 2023

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Saint Etienne
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	28
Start date	24 November 2021
Primary completion	6 April 2023
Estimated completion	6 April 2023
Sites	1 location across France

Drugs / interventions tested

• cognitive assessment
• Cold Pressor Test
• digital sensor of Nociception Level Index

Conditions studied

• Alzheimer Disease — all drugs for Alzheimer Disease →
• Pain — all drugs for Pain →
• Autonomic Nervous System Disease — all drugs for Autonomic Nervous System Disease →

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Who can join

Adults 60 to 80, any sex, with Alzheimer Disease or Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The most common form of dementia is Alzheimer's disease, with 900,000 people affected in France in 2015 and a forecast of 1.3 million in 2020. As a consequence of their advanced age, dementia patients often suffer from pain, mainly musculoskeletal or neuropathic pain. However, the exact prevalence of pain in dementia is underestimated. Indeed, several studies indicate that people suffering from dementia report less pain. This phenomenon is all the more true as the stage of dementia is advanced. In addition, people with dementia receive less pain medication than people without cognitive impairment in similarly painful conditions. Hetero-evaluation alone also seems insufficient, with the result that pain is under-treated compared to patients without cognitive impairment. Better pain screening is a major challenge and self-assessment tools should be favoured as a first line of treatment, even for patients with cognitive impairment. suffering from dementia.

The investigators propose in this work to evaluate the variation of vegetative parameters that accompany a painful stimulus. These variations can be recorded at the cardiac, vascular, pupillary or skin conductance level.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.