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CompletedPhase 3
Safety and Tolerability Study of Extended Release (ER) Galantamine in Alzheimer's Disease
Galantamine ER Open Label Rapid Dose Escalation Trial in Alzheimer's Disease
Asset
Galantamine
Listed sites
0
Recruiting sites
-
Enrollment
83
actual
Study population
Alzheimer’s disease
Key I/E criteria
•Alzheimer's disease•MMSE 10-24
Primary endpoint
•Primary end point occurs
Identifiers
Registered as
Org study IDCR004699
NCT IDNCT00082602
Timeline
Milestones
Study start2004-05 (month precision)
Study first posted2004-05-17estimated
Study completion2005-04actual (month precision)
Last update posted2011-05-20estimated
Assets
Drug assets
Study populations
Who this study enrolls
Alzheimer’s disease
Eligibility
Who can enroll
Minimum age60 Years
SexAll
Healthy volunteersNot accepted
Inclusion criteria
•Male or female outpatients diagnosed with Alzheimer's Disease
•Age >= 60 years
•Presence of mild to moderate dementia as evidenced by Mini Mental State Examination (MMSE) score of 10-24 inclusive at screening
•History of cognitive decline that had been gradual in onset and progressive over a period of at least six months
Exclusion criteria
•Neurodegenerative disorders
•One of the following conditions possibly resulting in cognitive impairment: Acute cerebral trauma or injuries secondary to chronic trauma (such as boxing), hypoxic cerebral damage, whether or not due to acute or chronic cerebral hypoperfusion
•Vitamin deficiency states, such as folate, vitamin B12 or other B complex deficiencies
•Neurosyphilis or other infections resulting in cerebral abscesses, meningitis, or encephalitides such as AIDS
•Primary or metastatic cerebral neoplasia
•Significant endocrine or metabolic disease e.g., untreated or uncontrolled thyroid, parathyroid or pituitary disease, Cushing's syndrome, severe renal failure or uncontrolled diabetes mellitus
•Mental retardation or oligophrenia
•Multi-infarct dementia or clinically active cerebrovascular disease as evidenced by: a history of a significant cerebrovascular event yielding a physical or neurologic deficit likely to confound the assessment of the subject's intellectual function, multiple focal signs on neurological examination indicative of multiple ischemic attacks, significant findings on an available CT or MRI scan taken within the last 12 months
•Subjects with the following co-existing medical conditions: Any history of epilepsy or convulsions except for febrile convulsions during childhood
•Current clinically significant psychiatric disease, in particular current major depression, schizophrenia, bipolar disorder, moderate to severe or uncontrolled behavioral disturbances
•Peptic ulcer disease: if the ulcer is considered to be still active, or if treatment is not successful (symptoms present)
•Clinically significant hepatic, renal, pulmonary, metabolic or endocrine disturbances
•Clinically significant urinary outflow obstruction
•Current, clinically significant cardiovascular disease that would be expected to limit the subject's ability to participate in and complete a 12-Week trial. The following would usually be considered clinically significant cardiovascular diseases: cardiac surgery or myocardial infarction within the past 6 months, angina or coronary artery disease that required a change in anti-angina medication within the last 3 months, decompensated congestive heart failure, cardiac disease potentially resulting in syncope, near syncope or other alterations of mental status, atrial fibrillation, bradycardia < 50/min., atrio-ventricular block > first degree
•Severe mitral or aortic valvular disease
•Uncontrolled high blood pressure (systolic blood pressure > 170 mmHg or diastolic blood pressure > 110 mmHg) or sustained hypotension
•Any agent being used for the treatment of dementia (approved, experimental or over the counter agents
•Subjects who have previously received Cognexâ, Ariceptâ, metrifonate, Exelonâ, Reminyl, or Namendaâ for treatment of Alzheimer's disease, no matter if approved or experimental can be included in this trial provided that during the 30 days prior to baseline they were not taking these agents
•O History of drug or alcohol abuse within the last year or prior prolonged history of the same
•Female subjects of childbearing potential
•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 identical agents, or bromide
•Subjects who have previously been enrolled in other galantamine trials
•Subjects who have received an investigational medication within the last 30 days
•Conditions that could interfere with the absorption of the compound or with the evaluation of the disease
•Employees of the investigator
Endpoints (2)
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
Global cognition
1
Safety / tolerability / PK
1
Global cognition
1 endpointSecondary/protocol endpoint
The secondary end point occurs at Week 12. The secondary outcome measure will be the Mini Mental State Examination score.
Mini-Mental State Examination (MMSE)
descriptive
Safety / tolerability / PK
1 endpointPrimary/protocol endpoint
The primary end point occurs at Week 8. The primary outcome measures will be tolerability and safety through rates of adverse events.
event count, event
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.