NCT00814502

Does Zolpidem CR Treatment Change Clinical Outcomes in Elderly Hospitalized Patients With Dementia- A Pilot Study

Completed NA Results posted Last updated 12 April 2017

What this trial tests

NA trial testing Zolpidem CR in Dementia in 20 participants. Completed in 1 December 2013.

Timeline

1 December 2008

Primary endpoint
1 December 2013

1 December 2013

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	20
Start date	1 December 2008
Primary completion	1 December 2013
Estimated completion	1 December 2013
Sites	1 location across United States

Drugs / interventions tested

• Zolpidem CR — full drug profile →
• Placebo

Conditions studied

• Dementia — all drugs for Dementia →
• Alzheimer Disease — all drugs for Alzheimer Disease →
• Dementia, Vascular — all drugs for Dementia, Vascular →
• Sleep Disorders — all drugs for Sleep Disorders →

Sponsor

Massachusetts General Hospital

Who can join

Adults 60 to 99, any sex, with Dementia or Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Sleep Efficiency
  Time frame: Post-intervention, up to 3 weeks
  Sleep efficiency during the down interval. The down interval signifies the period of time (in minutes) at night when subjects are in bed and trying to sleep. Sleep efficiency is calculated as (100\*sleep minutes)/\[time interval from sleep onset (as defined by the sleep latency) to sleep offset (the end of the last sleep episode in the Down interval)\]. The time period was different for each pati
• Sleep Minutes
  Time frame: post-intervention, up to 3 weeks
  Total sleep minutes during the down period. The down interval signifies the period of time (in minutes) at night when subjects are in bed and trying to sleep. The time period was different for each patient, it was their duration of hospitalization. The first 48 hours patients were not on the study drug, so the reported least squares mean is an estimate of the mean for the subsequent time period w

Sponsor's own description

The purpose of this research study is to compare the effectiveness of Zolpidem CR to that of placebo in improving sleep efficiency in people with dementia admitted to the hospital because of their symptoms. You can participate in this study if you have dementia of the Alzheimer's type or vascular dementia. This study involves placebo; a placebo is a tablet that looks exactly like Zolpidem CR, the study drug, but contains no active study drug. We will use placebos to see if the study results are due to the study drug or due to other reasons. Zolpidem CR is also called Ambien CR and is widely available by prescription. Zolpidem CR is approved by the U.S. Food and Drug Administration (FDA) for the short-term treatment of insomnia (trouble falling or staying asleep).

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pharmacotherapies for sleep disturbances in dementia.
   McCleery J, Cohen DA, Sharpley AL. · · 2016 · cited 63× · PMID 27851868 · DOI 10.1002/14651858.cd009178.pub3
2. Pharmacotherapies for sleep disturbances in dementia.
   McCleery J, Sharpley AL. · · 2020 · cited 62× · PMID 33189083 · DOI 10.1002/14651858.cd009178.pub4
3. Proteostasis failure exacerbates neuronal circuit dysfunction and sleep impairments in Alzheimer's disease.
   Morrone CD, Raghuraman R, Hussaini SA, Yu WH. · · 2023 · cited 40× · PMID 37085942 · DOI 10.1186/s13024-023-00617-4
4. Personalized medicine for pathological circadian dysfunctions.
   Skelton RL, Kornhauser JM, Tate BA. · · 2015 · cited 5× · PMID 26150790 · DOI 10.3389/fphar.2015.00125
5. Management of sleep disturbance related to Alzheimer disease and dementia: An updated review of ClinicalTrials.gov.
   Aldurdunji MM. · · 2025 · PMID 40797495 · DOI 10.1097/md.0000000000043725