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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00202124
First Posted: September 20, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Queen's University
  Purpose
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
Alzheimer's Disease Drug: Tryptophan Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Double Blind Medium Term Efficacy Study of Trp01 in Patients With Mild to Moderate Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • 1. MMSE score
  • 2. Alzheimer’s Disease Assessment Scale, cognitive subpart (ADAS-Cog) as an evaluation of cognitive functioning

Secondary Outcome Measures:
  • 1. Alzheimer’s Disease Cooperative Study – Clinical Global Impression of Change (ADCS-CGIC)
  • 2. Neuropsychiatric Inventory (NPI)
  • 3. Disability Assessment for Dementia (DAD)
  • 4. Physical Self-Maintenance Scale (PSMS)
  • 5. Functional Activities Questionnaire (FAQ)

Estimated Enrollment: 12
Study Start Date: April 2001
Estimated Study Completion Date: March 2002
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00202124


Locations
Canada, Ontario
Queen's University
Kingston, Ontario, Canada, K7L 3N6
Sponsors and Collaborators
Queen's University
Investigators
Study Chair: Donald F Weaver, MD, PhD Queen's University
  More Information

ClinicalTrials.gov Identifier: NCT00202124     History of Changes
Other Study ID Numbers: DFW-TRP01
First Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: December 9, 2005
Last Verified: November 2002

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Tryptophan
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs