Vascular Cognitive ImpairmentNCT01027858
PROMOTE: Promotion of the Mind Through Exercise
A study testing Aerobic-based exercise training in people with Vascular Cognitive Impairment, run by University of British Columbia at 1 site in Canada.
Trial summary
The investigators will conduct a proof-of-concept study to provide preliminary evidence of efficacy of aerobic-based exercise training for maintaining cognitive function, executive function, and everyday function in adults with mild vascular cognitive impairment. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Vascular Cognitive Impairment
- What is being tested?
- Aerobic-based exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2009to May 2015
- Phase
- Interventional
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The study will specifically recruit individuals who fulfill the diagnostic criteria for SIVCI as outlined by Erkinjuntti and colleagues (1), which requires the presence of both cognitive syndrome (as defined in Section A below) and small vessel ischaemic disease (as defined in Section B below).
- Cognitive Syndrome defined as:
- Dysexecutive Syndrome: Some impairment in goal formulation, initiation, planning, organizing, sequencing, executing, set-shifting and maintenance, or abstracting.
- Memory Deficit: Some impairment in recall, relative intact recognition, less severe forgetting, benefit from cues.
- Progression: Deterioration of A1 and A2 from a previous higher level of functioning that are not per se interfering with complex occupational and social activities.
- Small Vessel Ischaemic Disease defined as:
Show all 21Show fewer
- Evidence of relevant cerebrovascular disease by brain imaging (in the last 12 months) defined as the presence of both:
- Periventricular and deep white matter lesions: Patchy areas of low attenuation (intermediate density between that of normal white matter and that of intraventricular cerebro-spinal fluid) or diffuse symmetrical areas of low attenuation with ill defined margins extending to the centrum semiovale plus at least one lacunar infarct (correlating to the white matter grading scale greater than 3 from the Cardiovascular Health Study) (2,3); and ii. Absence of cortical and/or cortico-sub-cortical non-lacunar territorial infarcts and watershed infarcts, haemorrhages indicating large vessel disease, signs of normal pressure hydrocephalus, or other specific causes of white matter lesions (e.g., multiple sclerosis, leukodystrophies, sarcoidosis, brain irradiation, etc).
- Presence or a history of neurological signs as evidence for cerebrovascular disease such as hemiparesis, lower facial weakness, Babinski sign, sensory deficit, dysarthria, gait disorder, extrapyramidal signs consistent with sub-cortical brain lesion(s).
- In addition, individuals must meet the following inclusion criteria:
- Montreal Cognitive Assessment (MoCA) (4) score less than 26 at screening;
- MMSE (5) score of > 20 at screening;
- Community-dwelling;
- Lives in Metro Vancouver;
- Have a caregiver, family member, or friend who interacts with him/her on a weekly basis;
- Able to comply with scheduled visits, treatment plan, and other trial procedures;
- Must be able to read, write, and speak English in which psychometric tests are provided with acceptable visual and auditory acuity;
- Stable on a fixed dose of cognitive medications (e.g., donepezil, galantamine, rivastigmine, memantine, etc.) that is not expected to change during the 12-month study period, or, if they are not on any of these medications, they are not expected to start them during the 12-month study period;
- Provide a personally signed and dated informed consent document indicating that the individual (or a legally acceptable representative) has been informed of all pertinent aspects of the trial. In addition, an assent form will be provided at baseline and again at regular intervals;
- Able to walk independently; and
- Must be in sufficient health to participate in study's aerobic-based exercise training program. This will be based on medical history, vital signs, physical examination by study physicians, and written recommendation by family physician indicating individual's appropriateness to participate in an aerobic-based exercise training program.
Who cannot join
- Absence of relevant small vessel ischaemic lesions on an existing brain computed tomography (CT) or MRI;
- Diagnosed with another type of dementia (e.g., AD) or other neurological conditions (e.g., multiple sclerosis, Parkinson's disease, etc.) that affects cognition and mobility;
- At high risk for cardiac complications during exercise and/or unable to self-regulate activity or to understand recommended activity level (i.e., Class C of the American Heart Risk Stratification Criteria);
- Have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility;
- Taking medications that may negatively affect cognitive function, such as anticholinergics, including agents with pronounced anticholinergic properties (e.g., amitriptyline), major tranquilizers (typical and atypical antipsychotics), and anticonvulsants (e.g., gabapentin, valproic acid, etc.); or
- Individual who plans to participate or is enrolled in a clinical drug trial concurrent to this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Exercise on Cognition and Function in Seniors With Vascular Cognitive Impairment: A Randomized Controlled Trial
The investigators will conduct a proof-of-concept study to provide preliminary evidence of efficacy of aerobic-based exercise training for maintaining cognitive function, executive function, and everyday function in adults with mild vascular cognitive impairment.
Read the detailed description
A total of 70 adults diagnosed with Ischaemic Vascular Cognitive Impairment (SIVCI) will be randomized to either a 6 month thrice weekly walking program or usual care. After 6 months of intervention, they will be followed for an additional 6 months. There will be three measurement sessions: baseline, 6 months (end of intervention period); and 12 months.
- Conditions
- Vascular Cognitive Impairment
- Being tested
- Aerobic-based exercise training, CON (control; usual care)
- Keywords
- exercise, aerobic exercise training, vascular cognitive impairment, Mild Sub-cortical Ischaemic Vascular Cognitive Impairment (SIVCI)
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic-based exercise trainingBehavioural
Six months of thrice-weekly walking program that will gradually progress in intensity. Each training session will be 60 minutes (10 minutes of warm-up, 40 minutes of training, and 10 minutes of cool-down).
CON (control; usual care)Behavioural
Nutrition education and usual care as prescribed by neurologist
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AT (aerobic-based exercise training) Receives: Behavioral: Aerobic-based exercise training |
| 2 | Active comparator | CON (control; usual care) Receives: Behavioral: CON (control; usual care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
This is a proof-of-concept study. The primary endpoints are: ADAS-Cog
Measured: baseline, 6 months, and 12 months
EXIT-25
Measured: baseline, 6 months, and 12 months
ADCS-ADL
Measured: baseline, 6 months, and 12 months
Secondary outcomes (4)
Secondary outcomes of interest include: performance of specific executive processes
Measured: baseline, 6 months, and 12 months
Physical function
Measured: baseline, 6 months, and 12 months
Inflammatory biomarkers
Measured: baseline, 6 months, and 12 months
Serum glucose and lipids. These will be assessed at 6 and 12 months.
Measured: baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Vascular Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Stroke Network, Heart and Stroke Foundation of Canada
- Responsible party
- Principal investigator, Teresa Liu-Ambrose, University of British Columbia
- Investigators
- Teresa Liu-Ambrose, Ph.D, PT, Principal investigator, University of British ColumbiaJanice Eng, Ph.D, Study director, University of British ColumbiaLara Boyd, Ph.D, Study director, University of British ColumbiaRobin Hsiung, Ph.D, Study director, University of British ColumbiaClaudia Jacova, Ph.D, Study director, University of British ColumbiaHoward Feldman, MD, Study director, University of British ColumbiaPenny Brasher, Ph.D, Study director, University of British ColumbiaPhilip Lee, Ph.D, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027858
- Sponsor's protocol ID
- H09-00529
- Status last verified
- Feb 2022
- First submitted
- 7 Dec 2009
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liu-Ambrose T, Best JR, Davis JC, Eng JJ, Lee PE, Jacova C, Boyd LA, Brasher PM, Munkacsy M, Cheung W, Hsiung GR. Aerobic exercise and vascular cognitive impairment: A randomized controlled trial. Neurology. 2016 Nov 15;87(20):2082-2090. doi: 10.1212/WNL.0000000000003332. Epub 2016 Oct 19.
PubMed 27760869Liu-Ambrose T, Eng JJ, Boyd LA, Jacova C, Davis JC, Bryan S, Lee P, Brasher P, Hsiung GY. Promotion of the mind through exercise (PROMoTE): a proof-of-concept randomized controlled trial of aerobic exercise training in older adults with vascular cognitive impairment. BMC Neurol. 2010 Feb 17;10:14. doi: 10.1186/1471-2377-10-14.
PubMed 20158920Hsu CL, Best JR, Davis JC, Nagamatsu LS, Wang S, Boyd LA, Hsiung GR, Voss MW, Eng JJ, Liu-Ambrose T. Aerobic exercise promotes executive functions and impacts functional neural activity among older adults with vascular cognitive impairment. Br J Sports Med. 2018 Feb;52(3):184-191. doi: 10.1136/bjsports-2016-096846. Epub 2017 Apr 21.
PubMed 28432077Barha CK, Hsiung GR, Best JR, Davis JC, Eng JJ, Jacova C, Lee PE, Munkacsy M, Cheung W, Liu-Ambrose T. Sex Difference in Aerobic Exercise Efficacy to Improve Cognition in Older Adults with Vascular Cognitive Impairment: Secondary Analysis of a Randomized Controlled Trial. J Alzheimers Dis. 2017;60(4):1397-1410. doi: 10.3233/JAD-170221.
PubMed 29036816Dao E, Barha CK, Best JR, Hsiung GY, Tam R, Liu-Ambrose T. The Effect of Aerobic Exercise on White Matter Hyperintensity Progression May Vary by Sex. Can J Aging. 2019 Jun;38(2):236-244. doi: 10.1017/S0714980818000582. Epub 2019 Mar 14.
PubMed 30867079A history of the Arkansas State Dental Hygienists Association. Ark Dent J. 1987 Apr;58(1):43. No abstract available.
PubMed 3107531Barha CK, Dao E, Marcotte L, Hsiung GR, Tam R, Liu-Ambrose T. Cardiovascular risk moderates the effect of aerobic exercise on executive functions in older adults with subcortical ischemic vascular cognitive impairment. Sci Rep. 2021 Oct 7;11(1):19974. doi: 10.1038/s41598-021-99249-1.
PubMed 34620933Barha CK, Starkey SY, Hsiung GYR, Tam R, Liu-Ambrose T. Aerobic exercise improves executive functions in females, but not males, without the BDNF Val66Met polymorphism. Biol Sex Differ. 2023 Apr 3;14(1):16. doi: 10.1186/s13293-023-00499-7.
PubMed 37013586Barha CK, Hsiung GYR, Liu-Ambrose T. The Role of S100B in Aerobic Training Efficacy in Older Adults with Mild Vascular Cognitive Impairment: Secondary Analysis of a Randomized Controlled Trial. Neuroscience. 2019 Jul 1;410:176-182. doi: 10.1016/j.neuroscience.2019.04.052. Epub 2019 May 7.
PubMed 31075314Dao E, Best JR, Hsiung GR, Sossi V, Jacova C, Tam R, Liu-Ambrose T. Associations between cerebral amyloid and changes in cognitive function and falls risk in subcortical ischemic vascular cognitive impairment. BMC Geriatr. 2017 Jun 28;17(1):133. doi: 10.1186/s12877-017-0522-4.
PubMed 28659161Davis JC, Hsiung GR, Bryan S, Best JR, Eng JJ, Munkacsy M, Cheung W, Chiu B, Jacova C, Lee P, Liu-Ambrose T. Economic evaluation of aerobic exercise training in older adults with vascular cognitive impairment: PROMoTE trial. BMJ Open. 2017 Mar 29;7(3):e014387. doi: 10.1136/bmjopen-2016-014387.
PubMed 28360247Davis JC, Hsiung GY, Bryan S, Jacova C, Jacova P, Munkacsy M, Cheung W, Lee P, Liu-Ambrose T. Agreement between Patient and Proxy Assessments of Quality of Life among Older Adults with Vascular Cognitive Impairment Using the EQ-5D-3L and ICECAP-O. PLoS One. 2016 Apr 21;11(4):e0153878. doi: 10.1371/journal.pone.0153878. eCollection 2016.
PubMed 27101402Dao E, Hsiung GY, Sossi V, Jacova C, Tam R, Dinelle K, Best JR, Liu-Ambrose T. Exploring the effects of coexisting amyloid in subcortical vascular cognitive impairment. BMC Neurol. 2015 Oct 12;15:197. doi: 10.1186/s12883-015-0459-1.
PubMed 26459220
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Exercise on Cognition and Function in Seniors With Vascular Cognitive Impairment: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01027858
- Acronym / sponsor ID
- H09-00529
- Conditions
- Vascular Cognitive Impairment
- Keywords
- exercise, aerobic exercise training, vascular cognitive impairment, Mild Sub-cortical Ischaemic Vascular Cognitive Impairment (SIVCI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Stroke Network, Heart and Stroke Foundation of Canada
- Study start
- Dec 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 9 Dec 2009 (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 investigators will conduct a proof-of-concept study to provide preliminary evidence of efficacy of aerobic-based exercise training for maintaining cognitive function, executive function, and everyday function in adults with mild vascular cognitive impairment.
Detailed description
A total of 70 adults diagnosed with Ischaemic Vascular Cognitive Impairment (SIVCI) will be randomized to either a 6 month thrice weekly walking program or usual care. After 6 months of intervention, they will be followed for an additional 6 months. There will be three measurement sessions: baseline, 6 months (end of intervention period); and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Aerobic-based exercise trainingAT (aerobic-based exercise training) |
| 2 | Active comparator | Behavioral: CON (control; usual care)CON (control; usual care) |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- The study will specifically recruit individuals who fulfill the diagnostic criteria for SIVCI as outlined by Erkinjuntti and colleagues (1), which requires the presence of both cognitive syndrome (as defined in Section A below) and small vessel ischaemic disease (as defined in Section B below).
- Cognitive Syndrome defined as:
- Dysexecutive Syndrome: Some impairment in goal formulation, initiation, planning, organizing, sequencing, executing, set-shifting and maintenance, or abstracting.
- Memory Deficit: Some impairment in recall, relative intact recognition, less severe forgetting, benefit from cues.
- Progression: Deterioration of A1 and A2 from a previous higher level of functioning that are not per se interfering with complex occupational and social activities.
Key exclusion criteria (6 listed)
- Absence of relevant small vessel ischaemic lesions on an existing brain computed tomography (CT) or MRI;
- Diagnosed with another type of dementia (e.g., AD) or other neurological conditions (e.g., multiple sclerosis, Parkinson's disease, etc.) that affects cognition and mobility;
- At high risk for cardiac complications during exercise and/or unable to self-regulate activity or to understand recommended activity level (i.e., Class C of the American Heart Risk Stratification Criteria);
- Have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility;
- Taking medications that may negatively affect cognitive function, such as anticholinergics, including agents with pronounced anticholinergic properties (e.g., amitriptyline), major tranquilizers (typical and atypical antipsychotics), and anticonvulsants (e.g., gabapentin, valproic acid, etc.); or
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 |
|---|---|---|
| Aerobic-based exercise trainingSix months of thrice-weekly walking program that will gradually progress in intensity. Each training session will be 60 minutes (10 minutes of warm-up, 40 minutes of training, and 10 minutes of cool-down). | Behavioural | 1 |
| CON (control; usual care)Nutrition education and usual care as prescribed by neurologist | Behavioural | 2 |
Primary outcome
This is a proof-of-concept study. The primary endpoints are: ADAS-Cog
Time frame: baseline, 6 months, and 12 months
EXIT-25
Time frame: baseline, 6 months, and 12 months
ADCS-ADL
Time frame: baseline, 6 months, and 12 months
4 secondary outcomes
Secondary outcomes of interest include: performance of specific executive processes
Time frame: baseline, 6 months, and 12 months
Physical function
Time frame: baseline, 6 months, and 12 months
Inflammatory biomarkers
Time frame: baseline, 6 months, and 12 months
Serum glucose and lipids. These will be assessed at 6 and 12 months.
Time frame: baseline, 6 months, and 12 months
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 25 Feb 2022.
- Background: PubMed 27760869Liu-Ambrose T, Best JR, Davis JC, Eng JJ, Lee PE, Jacova C, Boyd LA, Brasher PM, Munkacsy M, Cheung W, Hsiung GR. Aerobic exercise and vascular cognitive impairment: A randomized controlled trial. Neurology. 2016 Nov 15;87(20):2082-2090. doi: 10.1212/WNL.0000000000003332. Epub 2016 Oct 19.
- Background: PubMed 20158920Liu-Ambrose T, Eng JJ, Boyd LA, Jacova C, Davis JC, Bryan S, Lee P, Brasher P, Hsiung GY. Promotion of the mind through exercise (PROMoTE): a proof-of-concept randomized controlled trial of aerobic exercise training in older adults with vascular cognitive impairment. BMC Neurol. 2010 Feb 17;10:14. doi: 10.1186/1471-2377-10-14.
- Background: PubMed 28432077Hsu CL, Best JR, Davis JC, Nagamatsu LS, Wang S, Boyd LA, Hsiung GR, Voss MW, Eng JJ, Liu-Ambrose T. Aerobic exercise promotes executive functions and impacts functional neural activity among older adults with vascular cognitive impairment. Br J Sports Med. 2018 Feb;52(3):184-191. doi: 10.1136/bjsports-2016-096846. Epub 2017 Apr 21.
- Background: PubMed 29036816Barha CK, Hsiung GR, Best JR, Davis JC, Eng JJ, Jacova C, Lee PE, Munkacsy M, Cheung W, Liu-Ambrose T. Sex Difference in Aerobic Exercise Efficacy to Improve Cognition in Older Adults with Vascular Cognitive Impairment: Secondary Analysis of a Randomized Controlled Trial. J Alzheimers Dis. 2017;60(4):1397-1410. doi: 10.3233/JAD-170221.
- Background: PubMed 30867079Dao E, Barha CK, Best JR, Hsiung GY, Tam R, Liu-Ambrose T. The Effect of Aerobic Exercise on White Matter Hyperintensity Progression May Vary by Sex. Can J Aging. 2019 Jun;38(2):236-244. doi: 10.1017/S0714980818000582. Epub 2019 Mar 14.
- Background: PubMed 3107531A history of the Arkansas State Dental Hygienists Association. Ark Dent J. 1987 Apr;58(1):43. No abstract available.
- Background: PubMed 34620933Barha CK, Dao E, Marcotte L, Hsiung GR, Tam R, Liu-Ambrose T. Cardiovascular risk moderates the effect of aerobic exercise on executive functions in older adults with subcortical ischemic vascular cognitive impairment. Sci Rep. 2021 Oct 7;11(1):19974. doi: 10.1038/s41598-021-99249-1.
- Derived from this study: PubMed 37013586Barha CK, Starkey SY, Hsiung GYR, Tam R, Liu-Ambrose T. Aerobic exercise improves executive functions in females, but not males, without the BDNF Val66Met polymorphism. Biol Sex Differ. 2023 Apr 3;14(1):16. doi: 10.1186/s13293-023-00499-7.
- Derived from this study: PubMed 31075314Barha CK, Hsiung GYR, Liu-Ambrose T. The Role of S100B in Aerobic Training Efficacy in Older Adults with Mild Vascular Cognitive Impairment: Secondary Analysis of a Randomized Controlled Trial. Neuroscience. 2019 Jul 1;410:176-182. doi: 10.1016/j.neuroscience.2019.04.052. Epub 2019 May 7.
- Derived from this study: PubMed 28659161Dao E, Best JR, Hsiung GR, Sossi V, Jacova C, Tam R, Liu-Ambrose T. Associations between cerebral amyloid and changes in cognitive function and falls risk in subcortical ischemic vascular cognitive impairment. BMC Geriatr. 2017 Jun 28;17(1):133. doi: 10.1186/s12877-017-0522-4.
- Derived from this study: PubMed 28360247Davis JC, Hsiung GR, Bryan S, Best JR, Eng JJ, Munkacsy M, Cheung W, Chiu B, Jacova C, Lee P, Liu-Ambrose T. Economic evaluation of aerobic exercise training in older adults with vascular cognitive impairment: PROMoTE trial. BMJ Open. 2017 Mar 29;7(3):e014387. doi: 10.1136/bmjopen-2016-014387.
- Derived from this study: PubMed 27101402Davis JC, Hsiung GY, Bryan S, Jacova C, Jacova P, Munkacsy M, Cheung W, Lee P, Liu-Ambrose T. Agreement between Patient and Proxy Assessments of Quality of Life among Older Adults with Vascular Cognitive Impairment Using the EQ-5D-3L and ICECAP-O. PLoS One. 2016 Apr 21;11(4):e0153878. doi: 10.1371/journal.pone.0153878. eCollection 2016.
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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.
Teresa Liu-Ambrose, Ph.D, PT principal investigator
University of British Columbia
Janice Eng, Ph.D study director
University of British Columbia
Lara Boyd, Ph.D study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic-based exercise training in people with Vascular Cognitive Impairment, run by University of British Columbia 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 21 inclusion and 6 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 25 Feb 2022. 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?
This is a proof-of-concept study. The primary endpoints are: ADAS-Cog (time frame: baseline, 6 months, and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01027858, which also lists 13 linked publications.
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 25 Feb 2022.