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Double Blind Study of Trp01 in Patients With Alzheimer's Disease | Clinical Trials | Clareo Health

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

Double Blind Medium Term Efficacy Study of Trp01 in Patients With Mild to Moderate Alzheimer's Disease

NCT00202124•Queen's University

Summary

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

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

Age

0 - No limit years

Sex

ALL

Healthy Volunteers

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
+9 more 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:
•* 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
+17 more criteria

Locations (1)

Queen's University

Kingston, Ontario, Canada

Key Dates

Start Date

April 1, 2001

Completion Date

March 1, 2002

Last Updated

September 20, 2005

Enrollment

Estimated participants

Conditions

Alzheimer's Disease

Interventions

Tryptophan

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

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RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 20, 2005Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

ACP-204 in Adults With Alzheimer's Disease Psychosis

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