Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 12:17 AM
NCT ID:
NCT00814658
Eligibility Criteria:
Inclusion Criteria:
* Patients should fulfill DSM-IV criteria for dementia (APA, 1994)
* Patients should fulfill criteria for AD with cerebrovascular disease according to NINDS-AIREN criteria (Román et al., 1993)
* The severity of dementia should be mild to moderate, as defined by MMSE score between 10 and 26 (inclusive)
* Patients (and their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion Criteria:
* History of neurodegenerative disorders such as Parkinson's disease, Pick's disease or Huntington's chorea, Down's syndrome, Creutzfeldt-Jacob disease. Patients who have mild extrapyramidal signs, for which no treatment is required, are not excluded from the trial
* History of liver or renal insufficiency
* significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric, or metabolic disturbances in the past 6 months
* Patients who have previously received M1 agonists or cholinesterase inhibitors (tacrine, donepezil, metrifonate, rivastigmine) for treatment of Alzheimer's disease, no matter if approved or experimental can be included in this trial provided there was at least a washout period of 60 days prior to the screening assessments
* History of drug or alcohol abuse within the last year or prior prolonged history
* History of severe drug allergy or hypersensitivity
* including recorded hypersensitivity to cholinesterase inhibitors, choline agonists or similar agents, or bromide
* Subjects who have previously been enrolled in other galantamine trials.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT00814658
Study Brief:
Protocol Section:
NCT00814658