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

NCT00202124 | Completed Phase 4

• 1 other identifier: DFW-TRP01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

• 1. MMSE score

• 2. Alzheimer's Disease Assessment Scale, cognitive subpart (ADAS-Cog) as an evaluation of cognitive functioning

Secondary Outcomes (5)

• 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)

Interventions

Tryptophan DRUG

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Tryptophan

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Donald F Weaver, MD, PhD

  Queen's University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: April 1, 2001
• Study Completion: March 1, 2002
• Last Updated: September 20, 2005

Record last verified: 2002-11

Locations

CA (1)