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← Trials/Trial dossier/NCT00043849

CompletedPhase 4

Treatment of Agitation/Psychosis in Dementia/Parkinsonism (TAP/DAP)

Asset

Quetiapine

Listed sites

21

Recruiting sites

-

Enrollment

60

Study population

Alzheimer’s disease, Lewy body dementia

Key I/E criterion

•Multiple dementia etiologies

Primary endpoint

-

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 IDIA0034
NCT IDNCT00043849

Timeline

Milestones

Study start2002-07 (month precision)
Study first posted2002-08-15estimated
Primary completion2005-06actual (month precision)
Study completion2005-06actual (month precision)
Last update posted2009-12-11estimated

Assets

Drug assets

Quetiapine

Study populations

Who this study enrolls

Alzheimer’s diseaseLewy body dementia

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Fluent in English or Spanish.
•Presence of dementia as defined by the Diagnostic and Statistical Manual of Psychiatry, 4th ed. (DSM-IV) American Psychiatric Association. 1994.
•Meets NINDS/ADRDA diagnostic criteria for probable Alzheimer's disease [AD] or Consortium diagnostic criteria for probable dementia with Lewy bodies [DLB] or diagnostic criteria for Parkinson's disease with dementia [PDD].
•Presence of psychosis and/or agitation that interferes with daily activities:
a)psychosis,
b)hallucination,
c)delusion, or
d)agitation.
•Presence of 2 or more of the following extrapyramidal motor features:
a)resting tremor,
b)bradykinesia,
c)limb rigidity,
d)shuffling, short-stepped gait.
•Sum of ratings for the resting tremor, bradykinesia, rigidity and gait items of the Unified Parkinson's Disease Rating Scale (UPDRS) motor examination component must be greater than or equal to 2.
•Brief Psychiatric Rating Scale (BPRS) score greater than or equal to 12.
•Informed consent by participant or an appropriate proxy.
•Spouse/caregiver who is willing and able to accompany the subject to all clinic visits.
•A stable dosage of non-excluded medications for at least 2 weeks prior to the Screening Visit.
•Is in a stable medical condition for at least 4 weeks prior to the Screening Visit.
•Physically acceptable for this study as confirmed by medical history, physical exam and clinical laboratory tests.
•Must be able to ingest oral medications.
•Supervision must be available for administration of study medication.
•Taking any marketed cholinesterase inhibitor (donepezil [Aricept], rivastigmine [Exelon], galantamine [Reminyl], tacrine [Cognex], and/or memantine at a dose unchanged for at least 2 weeks prior to the screening visit.
•Participants may reside in their own home or in a supervised care setting, such as a nursing home

Exclusion criteria

•Mini Mental Status Examination Score <8.
•Use of any of the following in the 3 weeks prior to the screening visit: (a) a neuroleptic or atypical antipsychotic medication; or (b) an anticholinergic drug, amantadine for the treatment of parkinsonism [treatment with levodopa (Sinemet, Sinemet CR) and any dopamine agonist, selegiline or entacapone is allowed].
•A history of a severe adverse reaction to any antipsychotic medication.
•A serious medical illness that would preclude the safe administration of quetiapine, including active cancer. Skin tumors other than malignant melanoma are not exclusionary. Patients with stable prostate cancer may be included at the discretion of the Program Director.
•Current evidence or history in the last 2 years of epilepsy, focal brain lesion, head injury with loss of consciousness and/or immediate confusion after the injury.
•Known pregnancy.

Excluded Medications During the Study:

•Any classical neuroleptic antipsychotic, such as haloperidol (Haldol).
•Any atypical antipsychotic, such as risperidone (Risperidal), quetiapine (Seroquel), ziprasidone (Geodon), olanzapine (Zyprexa) and clozapine (Clozaril).
•Any anxiolytic other than lorazepam (Ativan), as described above. This includes clonazepam (Klonopin), diazepam (Valium), oxazepam (Serax), clorazepate (Tranxene), buspirone (Buspar) and hydroxyzine (Vistaril).
•Any hypnotic other than lorazepam (Ativan), as described above. This includes estazolam (Prosom), flurazepam (Dalmane), quazepam (Doral), temazepam (Restoril), triazolam (Halcion), diphenhydramine (Benadryl), doxylamine (Unisom), zolpidem (Ambien), zaleplon (Sonata) and chloral hydrate.

Endpoints (0)

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.

No endpoints recorded for this trial.

Publications (3)

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.