CompletedPhase 3

Safety and Efficacy of Galantamine in Patients With Dementia With Lewy Bodies

An Open Label 24-Week, Flexible Dose Trial to Assess the Safety and Efficacy of Galantamine in Patients With Dementia With Lewy Bodies

Lead sponsor

Neurological Research Center

Asset

Galantamine

Listed sites

Recruiting sites

Enrollment

Study population

Lewy body dementia

Key I/E criteria

•Dementia with Lewy bodies•MMSE ≥7•Study partner/caregiver required

Primary endpoints

•Neuropsychiatric Inventory (NPI)•ADCS-CGIC•COGDRAS

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 IDGAL-ALZ-421

NCT IDNCT00230997

Timeline

Milestones

Study start2002-12 (month precision)

Study completion2004-08 (month precision)

Study first posted2005-10-03estimated

Last update posted2005-12-16estimated

Assets

Drug assets

Galantamine

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age51 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female subjects (>50 years old) diagnosed with Dementia with Lewy bodies, in accordance with the consensus criteria for probable Dementia with Lewy bodies (McKeith et al., 1996) viii.

•NPI score ≥ 8 at screening

•MMSE ≥ 7 at screening

•Subjects living at home or in a residential or community care home. Subjects who live with or have regular daily visits from a responsible caregiver. Subjects must be able to read, write, and fully understand the language of the scales used in this trial.

•Subjects must exhibit sufficient visual, hearing, and communication capabilities

•The Informed Consent must be given by the subject and the subject's legally acceptable representative.

•The informed consent must also be signed by the caregiver.

•CT or MRI within last 12 months - to be performed if not done

Exclusion criteria

•Neurodegenerative disorders such as Alzheimer's disease, Frontotemporal dementia, including Pick's disease, Korsakoff's syndrome, Huntington's chorea, Down's syndrome, Creutzfeldt-Jacob disease and causes of Parkinsonism other than DLB.

•One of the following conditions possibly resulting in cognitive impairment:

-Acute cerebral trauma, subdural hematoma and injuries secondary to chronic trauma (such as boxing).

-Hypoxic cerebral damage whether or not due to acute or chronic cerebral hypoperfusion,

-Vitamin deficiency state such as folate, vitamin B12 and other B complex deficiencies, e.g., thiamine deficiency in Korsakoff's syndrome. Note: subjects taking regular B12 and folate are not necessarily excluded (treatment must be stable, ongoing for at least 4 weeks prior to entry).

-Infection such as cerebral abscess, neurosyphilis, meningitis or encephalitis.

-Primary or metastatic cerebral neoplasia.

-Significant endocrine or metabolic disease e

-Mental retardation or oligophrenia. Multi-infarct dementia or clinically active cerebrovascular disease

•Subjects with the following co-existing medical condition:

-Any history of epilepsy or convulsions except for febrile convulsions during childhood.

-Current clinically significant psychiatric disease, as judged by DSM-IV criteria, in particular current major depression or schizophrenia.

-Peptic ulcer: if the ulcer is to be considered still "active", i.e., treatment for this condition started <3 months ago or if treatment is not successful (still symptoms present), the subject is not eligible.

-Clinically significant hepatic, renal, pulmonary, metabolic or endocrine disturbances.

-Current, clinically significant cardiovascular disease that would be expected to limit the subject's ability to participate in and complete a 7-month trial.

-Any agent being used for the treatment of dementia (approved, experimental or over the counter agents),

•History of drug or alcohol abuse within the last year or prior prolonged history.

•Female subject of childbearing potential without adequate contraception. Females who are breast-feeding are also excluded.

•Subjects who, in the opinion of the investigator, are otherwise unsuitable for a trial of this type.

•History of severe drug allergy or hypersensitivity; including recorded hypersensitivity to cholinesterase inhibitors, choline agonists or similar agents, bromide or the components of the drug under study.

•Subjects who have previously been enrolled in other galantamine HBr trials. Subjects who were screened for previous galantamine studies but not enrolled may be re-screened for this study.

•Subjects on antipsychotics other than Risperdal® (risperidone), Zyprexa® (olanzapine), Seroquel® (quetiapine), Geodon® (ziprasidone).

•Conditions that could interfere with the absorption of the compound or with the evaluation of the disease.

Endpoints (8)

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

Other (unclassified)

Global cognition

Function / daily living

Behavior / neuropsychiatric

Global cognition

2 endpoints

Secondary/protocol endpoint

MMSE

Mini-Mental State Examination (MMSE)

descriptive

Secondary/protocol endpoint

ADAS-Cog

descriptive

Function / daily living

1 endpoint

Secondary/protocol endpoint

ADCS-ADL

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Behavior / neuropsychiatric

1 endpoint

Primary/protocol endpoint

NPI-12

Neuropsychiatric Inventory (NPI)

descriptive

Other (unclassified)

4 endpoints

Primary/protocol endpoint/low confidence

ADCS-CGIC

descriptive

Primary/protocol endpoint/low confidence

COGDRAS

descriptive

Secondary/protocol endpoint/low confidence

PSQI

descriptive

Secondary/protocol endpoint/low confidence

Concomitant Antipsychotic Medication use

descriptive

Publications (17)

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.