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CompletedPhase 4

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

Lead sponsor

Queen's University

Asset

Tryptophan

Listed sites

Recruiting sites

Enrollment

Study population

Alzheimer’s disease

Key I/E criterion

•Age ≥0

Primary endpoints

•Mini-Mental State Examination (MMSE)•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDDFW-TRP01

NCT IDNCT00202124

Timeline

Milestones

Study start2001-04 (month precision)

Study completion2002-03 (month precision)

Study first posted2005-09-20estimated

Last update posted2005-09-20estimated

Assets

Drug assets

Tryptophan

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age0 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Function / daily living

Behavior / neuropsychiatric

Other clinical outcomes

Other (unclassified)

Global cognition

2 endpoints

Primary/protocol endpoint

1. MMSE score

Mini-Mental State Examination (MMSE)

descriptive

Primary/protocol endpoint

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

ADAS-Cog

descriptive

Function / daily living

2 endpoints

Secondary/protocol endpoint

3. Disability Assessment for Dementia (DAD)

descriptive

Secondary/protocol endpoint

5. Functional Activities Questionnaire (FAQ)

descriptive

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

2. Neuropsychiatric Inventory (NPI)

Neuropsychiatric Inventory (NPI)

descriptive

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

1. Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

4. Physical Self-Maintenance Scale (PSMS)

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.