Status:

RECRUITING

Paradoxical Lucidity in Severe End-Stage Dementia

Lead Sponsor:

NYU Langone Health

Collaborating Sponsors:

National Institute on Aging (NIA)

Conditions:

Dementia

Eligibility:

All Genders

18+ years

Brief Summary

Cognitive decline in dementia is considered irreversible, however episodes of paradoxical lucidity (PL) in severe dementia suggest other mechanisms may be in play. Beyond anecdotal reports of transien...

Eligibility Criteria

Inclusion

  • Age \> 18 years
  • Advanced (severe) dementia diagnosed using the Global Deterioration Scale (GDS) with a score of 7 or the Palliative Performance Scale (PPS) with a score of less than 30%
  • Accepted for hospice care based on the Medicare eligibility guidelines
  • No longer being provided with nutrition or fluids
  • Anuria (dry diaper) or less than 200cc urine (almost dry diaper) in any 24-hour period

Exclusion

  • Cognitive or functional impairment due to a diagnosis other than dementia
  • Dementia with a GDS score \<7 (mild, moderate, moderately severe dementia). Please refer to rationale outlined for inclusion criteria 2.

Key Trial Info

Start Date :

June 2 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

May 31 2026

Estimated Enrollment :

520 Patients enrolled

Trial Details

Trial ID

NCT05234866

Start Date

June 2 2022

End Date

May 31 2026

Last Update

August 14 2025

Active Locations (1)

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1

NYU Langone Health

New York, New York, United States, 10016