Alzheimer's DiseasePhase 4NCT00202124
Double Blind Study of Trp01 in Patients With Alzheimer's Disease
A Phase 4 study testing Tryptophan in people with Alzheimer's Disease, run by Queen's University at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether tryptophan is effective in the treatment of mild to moderate Alzheimer's Disease (AD). Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Tryptophan
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2001to Mar 2002
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blind Medium Term Efficacy Study of Trp01 in Patients With Mild to Moderate Alzheimer's Disease
The purpose of this study is to determine whether tryptophan is effective in the treatment of mild to moderate Alzheimer's Disease (AD).
Read the 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.
- Conditions
- Alzheimer's Disease
- Being tested
- Tryptophan
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TryptophanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startApr 2001
- Study completionMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Investigators
- Donald F Weaver, MD, PhD, Study chair, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202124
- Sponsor's protocol ID
- DFW-TRP01
- Status last verified
- Nov 2002
- First submitted
- 13 Sep 2005
- Last updated
- 20 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Medium Term Efficacy Study of Trp01 in Patients With Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00202124
- Acronym / sponsor ID
- DFW-TRP01
- Conditions
- Alzheimer's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Apr 2001
- Study completion
- Mar 2002
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- Dementia according to DSM-IV criteria :
- Dementia according to communicative disorders and stroke criteria (NINCDS-ADRDA)
- 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)
Key exclusion criteria (27 listed)
- Patients with any other cause of dementia as evidenced by medical history, general physical and neurological examination, laboratory tests, and neuroradiological findings:
- Patients with other relevant concomitant diseases:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tryptophan | Drug | – |
Primary outcome
1. MMSE score
2. Alzheimer's Disease Assessment Scale, cognitive subpart (ADAS-Cog) as an evaluation of cognitive functioning
5 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald F Weaver, MD, PhD study chair
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tryptophan in people with Alzheimer's Disease, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. MMSE score. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2005.