Memory medications in older adults with Alzheimer’s: do they help or hinder during episodes of confusion?

To maintain or discontinue Cholinesterase Inhibitors in patients with Delirium superimposed on Alzheimer's Disease - a pilot clinical trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

REBEC

Registry ID

RBR-10xx8ftw

Enrollment

Registered

2025-11-11

Start date

2025-11-17

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia in Alzheimer&apos

Interventions

This is a single-center, randomized pilot clinical trial. There will be a total of 40 participants, with 20 in the intervention group and 20 in the control group. The randomization process will be car

s prescription will be modified to deprescribe the cholinesterase inhibitor in use at a different pace according to the patient&apos

s level of consciousness. If the patient is stuporous, lethargic, or drowsy, the medication will be abruptly discontinued, whereas if the patient is alert, the deprescription will be gradual, with hal

Eligibility

Age

60 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients of both sexes; aged 60 years or older; hospitalized in the geriatrics and orthopedics wards of the Clinical Hospital of the Botucatu Medical School at São Paulo State University (HCFMB-UNESP); presenting with hypoactive delirium superimposed on Alzheimer's disease or mixed Alzheimer's/vascular dementia with prior use of anticholinesterase medications for at least one month

Exclusion criteria

Exclusion criteria: Presence of hyperactive delirium at the time of recruitment; use of vasoactive drugs at the time of recruitment; heart rate below 50 bpm at the time of recruitment; abusive use of alcohol or illicit psychoactive substances in the past month; history of alcohol withdrawal in the last six months; presence of other forms of dementia.

Design outcomes

Primary

Measure	Time frame
We will determine the feasibility and statistical parameters required for a Phase III clinical trial, based on recruitment and retention rates, and intervention implementation. We will use the traffic light (Red / Amber / Green) approach to determine whether the study’s findings support a decision to proceed with a larger, phase III trial. According to that approach, measures below the red threshold indicate that the study is not feasible and should not progress further. Measures above the green threshold indicate that the study is feasible and researchers may proceed with the phase III study, while measures between the two, i.e., amber, indicate that it might be feasible if appropriate changes are implemented.	—

Measure

Time frame

We will determine the feasibility and statistical parameters required for a Phase III clinical trial, based on recruitment and retention rates, and intervention implementation. We will use the traffic light (Red / Amber / Green) approach to determine whether the study’s findings support a decision to proceed with a larger, phase III trial. According to that approach, measures below the red threshold indicate that the study is not feasible and should not progress further. Measures above the green threshold indicate that the study is feasible and researchers may proceed with the phase III study, while measures between the two, i.e., amber, indicate that it might be feasible if appropriate changes are implemented.

—

Secondary

Measure	Time frame
We will assess episodes of clinical complications using data extracted from the patient's medical records, recording the number of episodes of falls, nausea, vomiting, cardiovascular instability, and the need for vasoactive drugs, quantified in whole numbers;We will assess the occurrence of in-hospital death using data extracted from the patient's medical records, noting whether or not such an event took place ;We will estimate the impact of delirium on functional status using the Barthel Index, by comparing scores obtained during the pre-intervention assessment and at hospital discharge or at the end of patient follow-up;We will assess the rate of delirium improvement using the 20-item 3D-CAM-S scale (3-minute interview based on the Confusion Assessment Method – Severity Scale), by monitoring a continuous scoring curve;We will assess the persistence of the delirium diagnosis using the 20-item 3D-CAM-S tool (a 3-minute interview based on the Confusion Assessment Method – Severity Scale), determining resolution of the delirium episode after two consecutive evaluations indicating absence of delirium;We will assess the length of hospital stay using data extracted from the patient's medical records, considering the total number of complete days ;We will assess the number of episodes of psychomotor agitation, the number of episodes requiring rescue medication, and the number of episodes requiring mechanical restraint, as well as the duration of mechanical restraint. These data will be extracted from the patient's medical records and quantified in whole numbers	—

Measure

Time frame

We will assess episodes of clinical complications using data extracted from the patient's medical records, recording the number of episodes of falls, nausea, vomiting, cardiovascular instability, and the need for vasoactive drugs, quantified in whole numbers;We will assess the occurrence of in-hospital death using data extracted from the patient's medical records, noting whether or not such an event took place ;We will estimate the impact of delirium on functional status using the Barthel Index, by comparing scores obtained during the pre-intervention assessment and at hospital discharge or at the end of patient follow-up;We will assess the rate of delirium improvement using the 20-item 3D-CAM-S scale (3-minute interview based on the Confusion Assessment Method – Severity Scale), by monitoring a continuous scoring curve;We will assess the persistence of the delirium diagnosis using the 20-item 3D-CAM-S tool (a 3-minute interview based on the Confusion Assessment Method – Severity Scale), determining resolution of the delirium episode after two consecutive evaluations indicating absence of delirium;We will assess the length of hospital stay using data extracted from the patient's medical records, considering the total number of complete days ;We will assess the number of episodes of psychomotor agitation, the number of episodes requiring rescue medication, and the number of episodes requiring mechanical restraint, as well as the duration of mechanical restraint. These data will be extracted from the patient's medical records and quantified in whole numbers

—

Countries

Contacts

Public ContactOctavio Fenelon Costa

Departamento de Saúde Pública - Faculdade de Medicina de Botucatu

octavio.costa@unesp.br+55 (14) 99185 8329

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Apr 4, 2026