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:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT00376051
Eligibility Criteria:
Inclusion Criteria:
* Meet the DSM-IV criteria for primary degenerative dementia
* Meet standard clinical criteria for frontotemporal dementia (ie., frontotemporal degeneration including both the frontal/behavioural variant and primary progressive aphasia)
* Have significant behavioural problems as demonstrated by a score of at least eight on the Neuropsychiatric Inventory (NPI) an
* An independent clinical decision to receive psychotropic medication for behavioural disorders
Exclusion Criteria:
* An abnormal biochemical screening (blood cell count, vitamin B12 or thyroid function tests)
* Significant medical illness or other medical/neurological conditions which diminish cognitive function (including: drug overdose, severely disturbed liver, kidney, lung or heart function, anemia, hypothyroidism, vitamin B12 or folic acid deficiency, syphilis, uncontrolled diabetes, Parkinson's disease, Huntington's chorea, progressive supranuclear paralysis, brain tumour, subdural hematoma, multiple sclerosis, or brain trauma);
* An Hachinski ischemic score ≥444;
* Electrocardiographic, laboratory or physical evidence of significant cardiovascular disease;
* Hypertension \>160 mmHg systolic or \>100 mmHg diastolic;
* A brain computed tomographic scan that could not be interpreted as consistent with FTLD;
* Presence of premorbid or current psychiatric diagnosis (including: major depression, schizophrenia, psychotic symptoms of a severity likely to provoke violent or dangerous behaviour such as command hallucinations to harm people or persecutory delusions that provoke violent reactions, psychoactive substance abuse or dependence);
* Contraindications to receiving citalopram (such as concomitant MAOI or within 2 weeks, or hypersensitivity to citalopram); or
* Ongoing need for psychotropic medications (i.e., unsuitable for washout) or administration of a depot antipsychotic injection within one treatment cycle of visit 1
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00376051
Study Brief:
Protocol Section:
NCT00376051