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CompletedPhase NAResults posted

Zolpidem CR and Hospitalized Patients With Dementia

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

Lead sponsor

Massachusetts General Hospital

Asset

Zolpidem

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease, Vascular cognitive impairment / dementia

Key I/E criterion

•Multiple dementia etiologies

Primary endpoints

•Sleep Efficiency•Sleep Minutes

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID2008-P-001434/1

NCT IDNCT00814502

Timeline

Milestones

Study start2008-12 (month precision)

Study first posted2008-12-25estimated

Primary completion2013-12actual (month precision)

Study completion2013-12actual (month precision)

Last update posted2017-05-22actual

Results first posted2017-05-22actual

Assets

Drug assets

Zolpidem

Study populations

Who this study enrolls

Alzheimer’s diseaseVascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age60 Years

Maximum age99 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age between 60-99 years

•Clinical diagnosis of Dementia of the Alzheimer's type or Vascular Dementia

•Only subjects with Mini Mental Status Examination scores of greater or equal to 10 will be enrolled

Exclusion criteria

1. Subjects who are too agitated to be able to wear the activity monitors;

2. Subjects who are actively suicidal or homicidal or for whom the clinical treatment team considers participation in the study to be unsuitable;

3. Subjects with untreated primary sleep disorders;

4. Subjects who receive hypnotic medications during their participation in the study; Subjects who received hypnotic medications prior to enrollment may participate in the study if they agree to stop receiving hypnotic medications (with their attending physician's approval);

5. Subjects who are receiving over the counter sleep aids;

6. Subjects who can not commit to abstaining from alcohol use while in the study;

7. Subjects with known anaphylactic reaction or angioedema with Zolpidem CR.

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric

Global cognition

2 endpoints

Secondary/protocol endpoint

Measures of Aggression, Psychosis, General Clinical Status, Cognitive Measures, Mood Symptoms

Time frame:post-intervention, up to 3 weeks

Mini-Mental State Examination (MMSE)

ratio, descriptive

Secondary/registry result

Measures of Aggression, Psychosis, General Clinical Status, Cognitive Measures, Mood Symptoms

Time frame:post-intervention, up to 3 weeks

Mini-Mental State Examination (MMSE)

ratio, descriptive

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Zolpidem CRNPI Total Scoren=8 Participants	18.00	5.72
RAGE Total Scoren=8 Participants	1.40	1.31
DBRS Total Scoren=8 Participants	22.64	0.56
MMSE Total Scoren=8 Participants	24.45	2.05
MADRS Total Scoren=8 Participants	22.96	4.75
PlaceboNPI Total Scoren=9 Participants	18.64	5.36
RAGE Total Scoren=9 Participants	5.82	2.07
DBRS Total Scoren=9 Participants	22.47	0.58
MMSE Total Scoren=9 Participants	21.57	1.93
MADRS Total Scoren=9 Participants	22.56	4.80

Behavior / neuropsychiatric

4 endpoints

Primary/protocol endpoint

Sleep Efficiency

Time frame:Post-intervention, up to 3 weeks

ratio, descriptive

Primary/protocol endpoint

Sleep Minutes

Time frame:post-intervention, up to 3 weeks

ratio, descriptive

Primary/registry result

Sleep Efficiency

Time frame:Post-intervention, up to 3 weeks

ratio, descriptive

Posted result

Group	Value (least_squares_mean), percentage of sleep (see above)	Standard error
Zolpidem CRn=8 Participants	75.93	3.24
Placebon=9 Participants	75.30	3.14

Primary/registry result

Sleep Minutes

Time frame:post-intervention, up to 3 weeks

ratio, descriptive

Posted result

Group	Value (least_squares_mean), sleep minutes	Standard error
Zolpidem CRn=8 Participants	443.71	30.11
Placebon=9 Participants	422.49	29.27

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.
PMID33189083via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.