Alzheimer's DiseaseDARAD-MRINCT00692588
MRI to Measure Treatment With Antibiotics in Alzheimer's Disease
An observational study of Alzheimer's Disease, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
Objectives: To study the changes in brain structure and function using MRI scans in patients treated for Alzheimer's disease. Methods: A pilot study of treating Alzheimer's disease with antibiotics showed some promise that this treatment could delay the deterioration of the mind with this disease. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- How many people
- 58 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2008to Jun 2010
- Phase
- Observational
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants in the DARAD Trial (Doxycycline and Rifampicin for Alzheimer's disease).
Who may be able to join
- (DARAD Trial)
- Male or female aged 50 years or older.
- Diagnosis of dementia using standardized DSM IV criteria and probable Alzheimer's disease (NINCDS-ADRDA criteria).
- SMMSE score 14-26 inclusive.
- Patients who have a consistent caregiver who will accompany them to clinic visits, ensure medication compliance, monitor and report adverse events and sign informed consent for his or her own participation.
- Sufficient visual, hearing and communication skills to complete standardized testing in English.
- Patients or their legally acceptable representatives for personal care who sign informed consent.
- Otherwise healthy on physical examination and screening physical and laboratory testing.
Who cannot join
- (DARAD Trial)
- Patients with neurodegenerative diseases such as Lewy Body dementia, Parkinson's disease, Fronto-temporal Dementia, Huntington's Chorea, Down's Syndrome or Creutzfeld Jacob Disease.
- Cognitive impairment which may be due to any of the following conditions:
- acute cerebral trauma, subdural hematoma, injuries from chronic trauma like boxing.
- Hypoxic cerebral damage e.g. post cardiac arrest, postanesthesia etc.
- Vitamin deficiency like B12 deficiency will be treated and stabilized for one month before patients will be randomized to the study. Patients taking B12 for more than one month can be included in the study.
Show all 35Show fewer
- Infections like cerebral abscesses, herpes, neurosyphilis, meningitis or AIDS.
- Primary or metastatic cerebral neoplasia.
- Endocrine deficiencies like hypercalcemia, hypothyroidism, hyperparathyroidism, Cushing's syndrome, severe renal failure, poorly controlled diabetes mellitus, pituitary disease, etc.
- Mental retardation. If a patient has one of these conditions and in the opinion of the investigator this condition has stabilized and is not contributing to the decline in cognition then this patient may be included in the study after the steering committee has reviewed the situation and approved participation.
- Multi-infarct dementia or significant cerebrovascular disease as evidenced by a) stroke with deficit that may confound the assessment of cognitive function or b) multiple focal signs on exam indicative of multiple ischemic events or c) findings on CT or MRI scan that show multiple lacunar infarcts, extensive periventricular white matter lesion, an infarct in the angular gyrus, the thalamus, the basal forebrain, the anterior or posterior cerebral artery territory.
- Patients with significant intracranial pathology such as tumour or hydrocephalus confirmed by CT or MRI in the past two years. The CT or MRI must be repeated before inclusion if the patient has experienced significant loss of consciousness or other neurological signs or symptoms, step-wise deterioration or has sustained a significant head injury since the last scan was performed. Patients with loss of consciousness, transient ischemic attacks or drop attacks, may be considered if these did not occur in the preceding twelve months.
- Patients with the following co-existing medical conditions:
- History of epilepsy or convulsions.
- Clinically significant psychiatric conditions (based on DSM-IV criteria) like major depression, schizophrenia. A Cornell Scale for Depression in Dementia score of 12 or more out of 38.
- Moderate to severe behavioural disturbances,
- Clinically significant hepatic, renal, pulmonary, metabolic or endocrine diseases.
- History of drug or alcohol abuse in the year prior to enrolment.
- History of myasthenia gravis.
- Clinically significant cardiac disease such as:
- Cardiac surgery in the past six months.
- Unstable angina or poorly controlled congestive heart failure (NYHA III or IV).
- Uncontrolled hypertension with systolic pressure greater that 180 mmHg. or diastolic pressure greater that 110 mmHg.
- Patients taking anti-dementia treatments with the following exceptions: donepezil, galantamine, rivastigmine, memantine, ASA up to 650 mg OD, Vitamin E 400 i.u., multi B vitamins, Ginko biloba, Cox II inhibitors or statins. In all cases the dose should have been stable for three months or more, and not be expected to change for the duration of the trial.
- Patients enrolled in other clinical trials with investigational drugs.
- Patients taking long term antibiotics (more than one month in the past six months).
- Allergies to these antibiotics.
- (MRI)
- Cardiac pacemaker or implantable defibrillator
- Cerebral aneurysm clip
- Neural stimulator (e.g. TENS-Unit)
- Any type of ear implant
- Ocular foreign body (e.g. metal shavings)
- Any implanted device (e.g. insulin pump, drug infusion device)
- Metal shrapnel or bullet.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Magnetic Resonance Imaging to Measure Treatment Effects of Doxycycline and Rifampicin in Alzheimer's Disease
Objectives:
To study the changes in brain structure and function using MRI scans in patients treated for Alzheimer's disease.
Read more
Methods:
A pilot study of treating Alzheimer's disease with antibiotics showed some promise that this treatment could delay the deterioration of the mind with this disease. This study is being replicated on a larger scale, providing a more definitive answer to this question. In addition to looking at changes of the mind (through cognitive tests), we would like to use MRI scans in these patients before and after treatment to study the structural changes and the chemical changes in the brain. This would provide a non-invasive look at the bran processes that protect the brain from the effect of Alzheimer's as well as confirming that the disease has been modified with treatment.
Impact:
The novel treatment of Alzheimer's with antibiotics has provided a potential breakthrough in the field. In addition to verifying changes in the brain, MRI scans can observe HOW this process could occur, thus opening doors to other new treatments for Alzheimer's and perhaps even cures.
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, Diffusion Tensor Imaging, Susceptibility Weighted Imaging, Doxycycline, Rifampicin
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Subjects who received placebo in DARAD Trial | |
| Doxycycline | Subjects who received doxycycline in DARAD Trial | |
| Rifampicin | Subjects who received rifampicin in DARAD Trial | |
| Doxycycline and Rifampicin | Subjects who received doxycycline and rifampicin in DARAD Trial | |
| Control | Normal controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in MRI Pre Vs Post Treatment
Measured: 1 Year
Secondary outcomes (1)
Comparison of Normal Controls Vs Alzheimer's Disease using MRI
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2010
- Study completionJun 2010
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- St. Peter's Hospital, St. Peter's Centre for Studies in Aging
- Investigators
- Mohammed A Warsi, (Hon)BSc, MSc, MD, FRCP(C), Principal investigator, McMaster UniversityMichael D Noseworthy, (Hon)BSc, MSc, PhD, Study director, St. Joseph's HospitalWilliam Molloy, MBBch, MRCP, FRCP(C), Study director, St. Peters Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692588
- Sponsor's protocol ID
- R.P. #07-2949
- Acronym
- DARAD-MRI
- Status last verified
- Apr 2011
- First submitted
- 4 Jun 2008
- Last updated
- 6 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging to Measure Treatment Effects of Doxycycline and Rifampicin in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00692588
- Acronym / sponsor ID
- DARAD-MRI / R.P. #07-2949
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, Diffusion Tensor Imaging, Susceptibility Weighted Imaging, Doxycycline, Rifampicin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- St. Peter's Hospital, St. Peter's Centre for Studies in Aging
- Study start
- Jun 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 6 Jun 2008 (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.
Objectives:
To study the changes in brain structure and function using MRI scans in patients treated for Alzheimer's disease.
Methods:
A pilot study of treating Alzheimer's disease with antibiotics showed some promise that this treatment could delay the deterioration of the mind with this disease. This study is being replicated on a larger scale, providing a more definitive answer to this question. In addition to looking at changes of the mind (through cognitive tests), we would like to use MRI scans in these patients before and after treatment to study the structural changes and the chemical changes in the brain. This would provide a non-invasive look at the bran processes that protect the brain from the effect of Alzheimer's as well as confirming that the disease has been modified with treatment.
Impact:
The novel treatment of Alzheimer's with antibiotics has provided a potential breakthrough in the field. In addition to verifying changes in the brain, MRI scans can observe HOW this process could occur, thus opening doors to other new treatments for Alzheimer's and perhaps even cures.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | – | –Subjects who received placebo in DARAD Trial |
| Doxycycline | – | –Subjects who received doxycycline in DARAD Trial |
| Rifampicin | – | –Subjects who received rifampicin in DARAD Trial |
| Doxycycline and Rifampicin | – | –Subjects who received doxycycline and rifampicin in DARAD Trial |
| Control | – | –Normal controls |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in the DARAD Trial (Doxycycline and Rifampicin for Alzheimer's disease).
Key inclusion criteria (8 listed)
- (DARAD Trial)
- Male or female aged 50 years or older.
- Diagnosis of dementia using standardized DSM IV criteria and probable Alzheimer's disease (NINCDS-ADRDA criteria).
- SMMSE score 14-26 inclusive.
- Patients who have a consistent caregiver who will accompany them to clinic visits, ensure medication compliance, monitor and report adverse events and sign informed consent for his or her own participation.
Key exclusion criteria (35 listed)
- (DARAD Trial)
- Patients with neurodegenerative diseases such as Lewy Body dementia, Parkinson's disease, Fronto-temporal Dementia, Huntington's Chorea, Down's Syndrome or Creutzfeld Jacob Disease.
- Cognitive impairment which may be due to any of the following conditions:
- Multi-infarct dementia or significant cerebrovascular disease as evidenced by a) stroke with deficit that may confound the assessment of cognitive function or b) multiple focal signs on exam indicative of multiple ischemic events or c) findings on CT or MRI scan that show multiple lacunar infarcts, extensive periventricular white matter lesion, an infarct in the angular gyrus, the thalamus, the basal forebrain, the anterior or posterior cerebral artery territory.
- Patients with significant intracranial pathology such as tumour or hydrocephalus confirmed by CT or MRI in the past two years. The CT or MRI must be repeated before inclusion if the patient has experienced significant loss of consciousness or other neurological signs or symptoms, step-wise deterioration or has sustained a significant head injury since the last scan was performed. Patients with loss of consciousness, transient ischemic attacks or drop attacks, may be considered if these did not occur in the preceding twelve months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in MRI Pre Vs Post Treatment
Time frame: 1 Year
1 secondary outcome
Comparison of Normal Controls Vs Alzheimer's Disease using MRI
Time frame: 1 Year
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 6 Apr 2011.
Related trials for Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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.
Mohammed A Warsi, (Hon)BSc, MSc, MD, FRCP(C) principal investigator
McMaster University
Michael D Noseworthy, (Hon)BSc, MSc, PhD study director
St. Joseph's Hospital
William Molloy, MBBch, MRCP, FRCP(C) study director
St. Peters Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, run by St. Joseph's Healthcare Hamilton 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 8 inclusion and 35 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 6 Apr 2011. 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.
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?
Changes in MRI Pre Vs Post Treatment (time frame: 1 Year). 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 6 Apr 2011.