Double Blind Study of Trp01 in Patients With Alzheimer's Disease

• Status: Completed
• Trial end date: 2002-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether tryptophan is effective in the treatment of mild to moderate Alzheimer's Disease (AD).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Queen's University
• Treatments: Tryptophan

Criteria

Inclusion Criteria:

Patients will be selected in order to fulfill both of the following definitions:

• Dementia according to DSM-IV criteria :

• development of multiple cognitive deficits manifested by both memory impairment and one or more of the following cognitive disturbances: aphasia, apraxia, agnosia, disturbance in executive functioning

• the above-mentioned deficits cause significant impairment in social or occupational functioning

• they do not occur exclusively during the course of delirium

• Dementia according to communicative disorders and stroke criteria (NINCDS-ADRDA)

• dementia established clinically and documented by a Folstein Mini-Mental State Examination (MMSE)

• deficits in two or more areas of cognition

• progressive worsening of memory and other cognitive functions

• no disturbance of consciousness

• absence of systematic disorders or other brain diseases that in and of themselves can account for progressive deficit in memory and cognition

Furthermore, patients must fulfill the following criteria:

• men, or postmenopausal or surgically sterilized women

• with severity of dementia of mild to moderate degree as reflected by a score of greater than 14 but less than 26 on the MMSE

• with a minimum one-year duration of the symptomatology (progressive worsening of memory and other cognitive functions)

• living at home or in an institution provided that they have reliable caregivers

• able to perform the required psychometric tests and evaluations. Visual and auditory acuity (with glasses or hearing aid if required) must be sufficient to complete the protocol-specified procedures.

• Clinical laboratory battery (see section 7.2.2) must yield results within normal limits or determined as not clinically significant by the study physician for the patient's sex and age

• Patients and their substitute decision-makers must have signed the written informed consent form

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:

• Vascular dementia, as evidenced by Modified Hachinski Ischemia Scale

• Depressive pseudementia, as evidenced by cognitive disturbances concomitant to a major depressive episode according to DSM-IV and/or a history of more than one major depressive episode

• DSM-IV criteria for any major psychiatric disorder including schizophrenia, alcohol or substance abuse

• Huntington's chorea or Parkinson's disease, evidenced by neurological examination, with an onset prior to or concurrent with dementia

• Creutzfeldt-Jakob disease

• Intracranial mass lesion

• Clinically important head injury

• History or current evidence of stroke

• Onset of dementia following cardiac arrest or heart surgery

• Neurosyphilis

• Seropositivity for HIV

• Vitamin B12 deficiency

• Uncorrected hypothyroidism (i.e. abnormal free T4, ultrasensitive TSH)

• Patients with other relevant concomitant diseases:

• Patients with history or current evidence of a sleep disorder

• Patients with a clinically significant cardiovascular, renal, hepatic, pulmonary, gastrointestinal, endocrine, metabolic, opthalmologic, or hematologic condition

• Current evidence or history within the past year of myocardial infarction (MI), congestive heart failure

• Blood pressure at screening of > 180 mm Hg systolic or 100 mm Hg diastolic

• Impaired renal, hepatic, or gastrointestinal function, which could interfere with drug absorption, metabolism or excretion

• Seizure disorder

• Diabetes

• Earlier diagnosis or current evidence of cataracts

• Progressive fatal disease (other than AD)

• Treatment with any other investigational drug in the last 8 weeks prior to screening

• Previous administration of TRP01