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Sponsored by: |
Queen's University |
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Information provided by: | Queen's University |
ClinicalTrials.gov Identifier: | NCT00202124 |
The purpose of this study is to determine whether tryptophan is effective in the treatment of mild to moderate Alzheimer's Disease (AD).
Condition | Intervention | Phase |
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Alzheimer's Disease |
Drug: Tryptophan |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Double Blind Medium Term Efficacy Study of Trp01 in Patients With Mild to Moderate Alzheimer's Disease |
Estimated Enrollment: | 12 |
Study Start Date: | April 2001 |
Estimated Study Completion Date: | March 2002 |
The clinical trial will be a double-blind, placebo-controlled study with patients being randomized in a 2:1 ratio into groups A and B, respectively:
Group A: TRP01 1g b.i.d. for 26 weeks
Group B: placebo capsules b.i.d. for 26 weeks
After the initial screening, clinic visits will take place at 0, 13 and 26 weeks. The blinding will be maintained until all patients have completed the 26-week trial. Any patients wishing to continue taking the medication upon completion of the trial will be provided a prescription for the drug and may purchase it at their own expense.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients will be selected in order to fulfill both of the following definitions:
Dementia according to DSM-IV criteria :
Dementia according to communicative disorders and stroke criteria (NINCDS-ADRDA)
Furthermore, patients must fulfill the following criteria:
Exclusion Criteria:
Patients with any of the following will not be included in the study:
Patients with any other cause of dementia as evidenced by medical history, general physical and neurological examination, laboratory tests, and neuroradiological findings:
Patients with other relevant concomitant diseases:
Study ID Numbers: | DFW-TRP01 |
Study First Received: | September 13, 2005 |
Last Updated: | September 13, 2005 |
ClinicalTrials.gov Identifier: | NCT00202124 History of Changes |
Health Authority: | Canada: Health Canada |
Tryptophan Alzheimer Disease Psychotropic Drugs Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Cognition Disorders |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Dementia Antidepressive Agents, Second-Generation Antidepressive Agents Delirium |
Tryptophan Alzheimer Disease Nervous System Diseases Psychotropic Drugs Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Pharmacologic Actions |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Therapeutic Uses Dementia Tauopathies Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |