Mild to Moderate Dementia Due to Alzheimer's DiseasePhase 2NCT03462121
A Clinical Study Evaluating the Efficacy and Safety of RPh201 Treatment in Individuals With Alzheimer's Disease With or Without Coexisting Cerebrovascular Disease
A Phase 2 study testing RPh201 in people with Mild to Moderate Dementia Due to Alzheimer's Disease and With or Without Coexisting Cerebrovascular Disease, run by Regenera Pharma Ltd at 5 sites in Canada.
Trial summary
This study is a randomized, double-blind, placebo-controlled, multicentre, Phase 2 study, with an optional open-label extension, to evaluate the safety, tolerability, and efficacy of RPh201 in subjects with mild to moderate AD who are eligible for enrollment in this study. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild to Moderate Dementia Due to Alzheimer's Disease, With or Without Coexisting Cerebrovascular Disease
- What is being tested?
- RPh201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 5 sitesCanada
- Study dates
- 1 Mar 2018to 30 Mar 2020
- Phase
- Phase 2
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subjects must be ≥65 years of age at the time of consent.
- Subjects 65-69 years old, inclusive, must have evidence of cerebrovascular disease.
- Meet National Institute on Aging-Alzheimer's Association 2011 criteria for All-Cause Dementia and have evidence for probable AD or possible AD with coexisting cerebrovascular disease. Coexisting cerebrovascular disease includes evidence of any of the following: cortical infarcts, subcortical and lacunar infarcts, macro or micro-hemorrhage, and small vessel ischemic microangiopathy.
- Willing and able to provide informed consent or, if incapable of informed consent, have a legally authorized representative willing to consent on their behalf.
- MMSE at screen visit: 15-22, inclusive.
- Cholinesterase inhibitors, memantine, and other background medications impacting cognition and mood, if used, are at stable doses for at least 6 weeks prior to screening.
Show all 12Show fewer
- A study partner is available who has adequate contact with the subject to administer study drug, oversee study drug compliance, report on adverse events (AEs), and provide meaningful input into scales and assessments.
- Adequate hearing, vision, and fluency in the language of testing.
- Magnetic resonance imaging (MRI) of the brain must reveal findings consistent with AD with or without coexisting cerebrovascular disease. In subjects for whom brain MRI is contraindicated (e.g., presence of a pacemaker), computed tomography (CT) of the brain is acceptable. Historic MRI or CT scans up to 18 months prior to screening may be used for inclusion unless there have been interval clinical events warranting an updated scan.
- Male subjects who are sexually active must agree to use one of the following acceptable methods of birth control from Screening and for at least one month after the last dose of study drug: abstinence (no sexual intercourse), male condom, or vasectomy.
- Subjects must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Optional FDG-PET sub-study: no contraindications to PET imaging. Individuals participating in the FDG-PET sub-study will be capped at 15 volunteers and a further cap may be imposed on the number enrolling in this sub-study without evidence of cerebrovascular disease.
Who cannot join
- Neurological or non-neurological conditions other than AD and cerebrovascular disease that, in the Investigator's opinion, contribute to, or provide alternative etiology for, the subject's dementia. Examples include, but are not limited to, brain tumors, clinically significant head injury, Parkinson's disease, current or prior excess use of alcohol that, in the investigator's judgment, has caused or significantly contributed to the subject's cognitive decline, or primary psychiatric disorders (e.g., schizophrenia or bipolar affective disorder).
- Unstable medical conditions which are likely to impact subject's ability to complete the trial and which are likely to confound AE assessment. These include, but are not limited to, uncontrolled hypertension, uncontrolled diabetes, and cancer within past the 2 years. Exceptions include prostate cancer in-situ and local basal and squamous cell skin cancers.
- Chronic use of systemic or inhaled steroids (use of topical steroids is acceptable).
- Other concomitant medications that, in the Investigator's judgment, impair cognition and/or confound efficacy assessments.
- Women of child-bearing potential are excluded (e.g., women who have not been post-menopausal for at least 2 years or are not surgically sterile).
- Treatment with investigational product from a previous clinical drug trial within the last 30 days or five half-lives prior to Visit 2 (Baseline), whichever is longer.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Recherches Neuro-Hippocampe Inc. d/b/a Clinique de la Memoire de l'Outaouais
Gatineau, Quebec, J8T 8J1
Kawartha Centre - Redefining Healthy Aging
Peterborough, Ontario, K9H 2P4
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, J1L 0H8
Toronto Memory Program
Toronto, Ontario, M3B 2S7
Gerontion Research Inc., The Center for Memory & Aging
Toronto, Ontario, M4G 3E8
About this study
Official title: A 6-Month, Double-Blind, Phase 2 Study and 6-Month Open- Label Extension Evaluating the Safety, Tolerability, and Clinical Benefit of RPh201 in Individuals With Alzheimer's Disease With or Without Coexisting Cerebrovascular Disease
This study is a randomized, double-blind, placebo-controlled, multicentre, Phase 2 study, with an optional open-label extension, to evaluate the safety, tolerability, and efficacy of RPh201 in subjects with mild to moderate AD who are eligible for enrollment in this study.
Subject participation will include a Screening Phase, Treatment Phase, and an Optional Open-Label Extension. The Screening Phase will be up to 4 weeks prior to randomization. Both the subject and their study partner(s) will sign an informed consent form (ICF). At Visit 2, Subjects will be randomized 2:1 to RPh201 or placebo. The Treatment Phase will last for 6 months post-randomization, or until subject withdrawal from the study, whichever comes first. The Optional Open-Label Extension will begin once a subject has completed the Treatment Phase and the subject and their study partner(s) have signed an ICF to continue on the study. The Optional Open-Label Extension will continue for 6 months, or until subject withdrawal from the study, whichever comes first. Subjects who do not participate in the Optional Open-Label Extension will be asked to return for an optional post-study visit 6 months after the end of the Treatment Phase.
Subjects may participate in an optional biomarker sub-study. Up to 15 subjects may also participate in an optional FDG-PET sub-study during their study participation. Separate informed consent will be required for both of these sub-studies.
- Conditions
- Mild to Moderate Dementia Due to Alzheimer's Disease, With or Without Coexisting Cerebrovascular Disease
- Being tested
- RPh201, Placebo
- Keywords
- Alzheimer's Disease,, Dementia
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPh201Drug
RPh201 is a well-defined extract from a botanical source
PlaceboOther
Also called Cottonseed oil
Inactive placebo consisting of the therapeutic vehicle
| Study group | Role | What they receive |
|---|---|---|
| RPh201 | Experimental | A 26-week schedule consisting of twice-weekly subcutaneous administration of 400 μL of the IMP (20 mg RPh201). Receives: Drug: RPh201 |
| Placebo | Placebo comparator | A 26-week schedule consisting of twice-weekly subcutaneous administration of 400 μL of the vehicle control. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in (Alzheimer disease assessment scale) ADAS-Cog score between Baseline and Month 6
The ADAS-Cog is an established general cognitive measure scaled used in clinical trials of AD. The ADAS-Cog assesses multiple performance and cognitive domains including memory, language, praxis, and orientation. Test responses are scored using summed error points where 0 represents no errors and 70 represents errors on all items; higher scores indicate greater cognitive impairment.
Measured: Month 6
Change in CDR-SB score between Baseline and Month 6
The CDR is a global clinical scale with established diagnostic and severity-ranking utility widely used in clinical trials yielding global and sum of boxes scores (CDR-SB). The CDR global score is used in AD trials as a global measure of disease severity. The CDR is rated based on subject and informant input. The CDR assess three domains of cognition (memory, orientation, judgment/problem solving) and three domains of function (community affairs, home/hobbies, personal care) using semi- structured interviews of both the study subject and a companion/informant carried out by a trained rater and scored using a standard methodology. Each domain is rated on a 5-point scale of functioning as follows: (0) no impairment; (0.5) questionable impairment; (1) mild impairment; (2) moderate impairment; (3) severe impairment (personal care is scored on a 4-point scale without a 0.5 rating available). Higher scores indicate greater impairment.
Measured: Month 6
AEs at Month 6
Measured: Month 6
12-lead ECG at Month 6
Measured: Month 6
Clinical Laboratory Assessments - (blood and urine) at at Month 6
Chemistry: alkaline phosphatase, albumin, blood urea nitrogen, calcium, chloride, creatinine, glucose (random), inorganic phosphorus, potassium, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transpeptidase, lactate dehydrogenase, sodium, direct bilirubin, total bilirubin, total protein, amylase, uric acid Hematology: haemoglobin, hematocrit, red blood cell count, white blood cell (WBC) count, WBC differential (absolute counts), numerical platelet count Urinalysis: specific gravity, pH, ketones, glucose, nitrite, blood, leukocyte esterase, protein, urobilinogen, bilirubin If nitrite, blood, or protein tests are positive, a microscopic examination will be performed
Measured: Month 6
Vital Signs
Vital signs consist of tympanic temperature, respiratory rate, blood pressure (systolic and diastolic blood pressure, mmHg), and pulse (bpm) after at least 3 minutes rest. Blood pressure will be measured in a sitting or semi-reclined seated position. Weight and height will be captured at Screening and weight will be captured at all other visits where this assessment is performed.
Measured: Month 6
Secondary outcomes (19)
Change from Baseline on ADAS-Cog total scores at Month 3
The ADAS-Cog is an established general cognitive measure scaled used in clinical trials of AD. The ADAS-Cog assesses multiple performance and cognitive domains including memory, language, praxis, and orientation. Test responses are scored using summed error points where 0 represents no errors and 70 represents errors on all items; higher scores indicate greater cognitive impairment.
Measured: Months 3
Change from Baseline on ADAS-Cog total scores at Month 5
The ADAS-Cog is an established general cognitive measure scaled used in clinical trials of AD. The ADAS-Cog assesses multiple performance and cognitive domains including memory, language, praxis, and orientation. Test responses are scored using summed error points where 0 represents no errors and 70 represents errors on all items; higher scores indicate greater cognitive impairment.
Measured: Month 5
Change from Baseline on ADAS-Cog total scores at Month 12
The ADAS-Cog is an established general cognitive measure scaled used in clinical trials of AD. The ADAS-Cog assesses multiple performance and cognitive domains including memory, language, praxis, and orientation. Test responses are scored using summed error points where 0 represents no errors and 70 represents errors on all items; higher scores indicate greater cognitive impairment.
Measured: Month 12
Change from Baseline on CDR-SB total scores at Month 3
The CDR is a global clinical scale with established diagnostic and severity-ranking utility widely used in clinical trials yielding global and sum of boxes scores (CDR-SB). The CDR global score is used in AD trials as a global measure of disease severity. The CDR is rated based on subject and informant input. The CDR assess three domains of cognition (memory, orientation, judgment/problem solving) and three domains of function (community affairs, home/hobbies, personal care) using semi- structured interviews of both the study subject and a companion/informant carried out by a trained rater and scored using a standard methodology. Each domain is rated on a 5-point scale of functioning as follows: (0) no impairment; (0.5) questionable impairment; (1) mild impairment; (2) moderate impairment; (3) severe impairment (personal care is scored on a 4-point scale without a 0.5 rating available). Higher scores indicate greater impairment.
Measured: Month 3
Change from Baseline on CDR-SB total scores at Month 5
The CDR is a global clinical scale with established diagnostic and severity-ranking utility widely used in clinical trials yielding global and sum of boxes scores (CDR-SB). The CDR global score is used in AD trials as a global measure of disease severity. The CDR is rated based on subject and informant input. The CDR assess three domains of cognition (memory, orientation, judgment/problem solving) and three domains of function (community affairs, home/hobbies, personal care) using semi- structured interviews of both the study subject and a companion/informant carried out by a trained rater and scored using a standard methodology. Each domain is rated on a 5-point scale of functioning as follows: (0) no impairment; (0.5) questionable impairment; (1) mild impairment; (2) moderate impairment; (3) severe impairment (personal care is scored on a 4-point scale without a 0.5 rating available). Higher scores indicate greater impairment.
Measured: Month 5
Change from Baseline on CDR-SB total scores at Month 12
The CDR is a global clinical scale with established diagnostic and severity-ranking utility widely used in clinical trials yielding global and sum of boxes scores (CDR-SB). The CDR global score is used in AD trials as a global measure of disease severity. The CDR is rated based on subject and informant input. The CDR assess three domains of cognition (memory, orientation, judgment/problem solving) and three domains of function (community affairs, home/hobbies, personal care) using semi- structured interviews of both the study subject and a companion/informant carried out by a trained rater and scored using a standard methodology. Each domain is rated on a 5-point scale of functioning as follows: (0) no impairment; (0.5) questionable impairment; (1) mild impairment; (2) moderate impairment; (3) severe impairment (personal care is scored on a 4-point scale without a 0.5 rating available). Higher scores indicate greater impairment.
Measured: Month 12
Change from Baseline in ADCS-ADL total score at Month 3
The ADCS-ADL is an assessment consisting of 23 basic and instrumental ADLs used in mild to moderate AD subjects.7 The scores of the informant-rated assessment are graded against a 78- point scale, with lower scores indicating greater impairment.
Measured: Month 3
Change from Baseline in ADCS-ADL total score at Months 12
The ADCS-ADL is an assessment consisting of 23 basic and instrumental ADLs used in mild to moderate AD subjects.7 The scores of the informant-rated assessment are graded against a 78- point scale, with lower scores indicating greater impairment.
Measured: Month 12
Change from Baseline in NPI total score at Month 3
The NPI is designed to detect, quantify, and track changes of psychiatric symptoms in a demented population.6 It uses a structured, caregiver-based interview format to assess 10 behavioral domains (delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, apathy, irritability, euphoria, disinhibition, and aberrant motor behavior). The same behaviors are then rated on level of severity (1 = mild, 2 = moderate, 3 = severe). The domain total score is the product of the frequency score multiplied by the severity score for that behavioral domain. An NPI total score is obtained by summing all the individual domain total scores.
Measured: Month 3
Change from Baseline in NPI total score at Month 6
The NPI (Appendix 7) is designed to detect, quantify, and track changes of psychiatric symptoms in a demented population.6 It uses a structured, caregiver-based interview format to assess 10 behavioral domains (delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, apathy, irritability, euphoria, disinhibition, and aberrant motor behavior). The same behaviors are then rated on level of severity (1 = mild, 2 = moderate, 3 = severe). The domain total score is the product of the frequency score multiplied by the severity score for that behavioral domain. An NPI total score is obtained by summing all the individual domain total scores.
Measured: Month 6
Change from Baseline in NPI total score at Month 12
The NPI (Appendix 7) is designed to detect, quantify, and track changes of psychiatric symptoms in a demented population.6 It uses a structured, caregiver-based interview format to assess 10 behavioral domains (delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, apathy, irritability, euphoria, disinhibition, and aberrant motor behavior). The same behaviors are then rated on level of severity (1 = mild, 2 = moderate, 3 = severe). The domain total score is the product of the frequency score multiplied by the severity score for that behavioral domain. An NPI total score is obtained by summing all the individual domain total scores.
Measured: Month 12
Change from Baseline in the MMSE at Month 3
The MMSE is a brief 30-point examination consisting of 11 questions intended to evaluate an adult subject's level of cognition. The MMSE evaluates 6 areas of cognition: orientation, attention, immediate recall, short-term recall, language, and the ability to follow simple verbal and written commands. In addition, it provides a total score allowing the examiner to evaluate the severity of cognitive impairment.
The MMSE will be scored using backward spelling (WORLD) and not serial subtractions. The scoring of WORLD will follow the original Folstein et al (1975)8 instructions for this assessment.
Measured: Month 3
Change from Baseline in the MMSE at Month 6
The MMSE is a brief 30-point examination consisting of 11 questions intended to evaluate an adult subject's level of cognition. The MMSE evaluates 6 areas of cognition: orientation, attention, immediate recall, short-term recall, language, and the ability to follow simple verbal and written commands. In addition, it provides a total score allowing the examiner to evaluate the severity of cognitive impairment.
The MMSE will be scored using backward spelling (WORLD) and not serial subtractions. The scoring of WORLD will follow the original Folstein et al (1975)8 instructions for this assessment.
Measured: Month 6
Change from Baseline in the MMSE at Month 12
The MMSE is a brief 30-point examination consisting of 11 questions intended to evaluate an adult subject's level of cognition. The MMSE evaluates 6 areas of cognition: orientation, attention, immediate recall, short-term recall, language, and the ability to follow simple verbal and written commands. In addition, it provides a total score allowing the examiner to evaluate the severity of cognitive impairment.
The MMSE will be scored using backward spelling (WORLD) and not serial subtractions. The scoring of WORLD will follow the original Folstein et al (1975)8 instructions for this assessment.
Measured: Month 12
AEs at Month 12
Measured: Month 12
Clinically significant changes in vital signs at Month 12
Measured: Month 12
12-lead ECG at Month 12
Measured: Month 12
Clinical Laboratory Assessments - (blood and urine) at Month 12
Chemistry: alkaline phosphatase, albumin, blood urea nitrogen, calcium, chloride, creatinine, glucose (random), inorganic phosphorus, potassium, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transpeptidase, lactate dehydrogenase, sodium, direct bilirubin, total bilirubin, total protein, amylase, uric acid Hematology: haemoglobin, hematocrit, red blood cell count, white blood cell (WBC) count, WBC differential (absolute counts), numerical platelet count Urinalysis: specific gravity, pH, ketones, glucose, nitrite, blood, leukocyte esterase, protein, urobilinogen, bilirubin If nitrite, blood, or protein tests are positive, a microscopic examination will be performed
Measured: Month 12
Vital Signs
Vital signs consist of tympanic temperature, respiratory rate, blood pressure (systolic and diastolic blood pressure, mmHg), and pulse (bpm) after at least 3 minutes rest. Blood pressure will be measured in a sitting or semi-reclined seated position. Weight and height will be captured at Screening and weight will be captured at all other visits where this assessment is performed.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start1 Mar 2018
- Primary completion28 Dec 2019
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate Dementia Due to 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regenera Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharon Cohen, MD, Principal investigator, Toronto Memory Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462121
- Sponsor's protocol ID
- RGN-ADC-002
- Status last verified
- Jun 2019
- First submitted
- 16 Feb 2018
- Last updated
- 30 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-Month, Double-Blind, Phase 2 Study and 6-Month Open- Label Extension Evaluating the Safety, Tolerability, and Clinical Benefit of RPh201 in Individuals With Alzheimer's Disease With or Without Coexisting Cerebrovascular Disease
- ClinicalTrials.gov ID
- NCT03462121
- Acronym / sponsor ID
- RGN-ADC-002
- Conditions
- Mild to Moderate Dementia Due to Alzheimer's Disease, With or Without Coexisting Cerebrovascular Disease
- Keywords
- Alzheimer's Disease,, Dementia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Regenera Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 28 Dec 2019 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 12 Mar 2018 (actual)
- 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.
This study is a randomized, double-blind, placebo-controlled, multicentre, Phase 2 study, with an optional open-label extension, to evaluate the safety, tolerability, and efficacy of RPh201 in subjects with mild to moderate AD who are eligible for enrollment in this study.
Subject participation will include a Screening Phase, Treatment Phase, and an Optional Open-Label Extension. The Screening Phase will be up to 4 weeks prior to randomization. Both the subject and their study partner(s) will sign an informed consent form (ICF). At Visit 2, Subjects will be randomized 2:1 to RPh201 or placebo. The Treatment Phase will last for 6 months post-randomization, or until subject withdrawal from the study, whichever comes first. The Optional Open-Label Extension will begin once a subject has completed the Treatment Phase and the subject and their study partner(s) have signed an ICF to continue on the study. The Optional Open-Label Extension will continue for 6 months, or until subject withdrawal from the study, whichever comes first. Subjects who do not participate in the Optional Open-Label Extension will be asked to return for an optional post-study visit 6 months after the end of the Treatment Phase.
Subjects may participate in an optional biomarker sub-study. Up to 15 subjects may also participate in an optional FDG-PET sub-study during their study participation. Separate informed consent will be required for both of these sub-studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RPh201 | Experimental | Drug: RPh201A 26-week schedule consisting of twice-weekly subcutaneous administration of 400 μL of the IMP (20 mg RPh201). |
| Placebo | Placebo comparator | Other: PlaceboA 26-week schedule consisting of twice-weekly subcutaneous administration of 400 μL of the vehicle control. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- Subjects must be ≥65 years of age at the time of consent.
- Subjects 65-69 years old, inclusive, must have evidence of cerebrovascular disease.
- Meet National Institute on Aging-Alzheimer's Association 2011 criteria for All-Cause Dementia and have evidence for probable AD or possible AD with coexisting cerebrovascular disease. Coexisting cerebrovascular disease includes evidence of any of the following: cortical infarcts, subcortical and lacunar infarcts, macro or micro-hemorrhage, and small vessel ischemic microangiopathy.
- Willing and able to provide informed consent or, if incapable of informed consent, have a legally authorized representative willing to consent on their behalf.
- MMSE at screen visit: 15-22, inclusive.
Key exclusion criteria (6 listed)
- Neurological or non-neurological conditions other than AD and cerebrovascular disease that, in the Investigator's opinion, contribute to, or provide alternative etiology for, the subject's dementia. Examples include, but are not limited to, brain tumors, clinically significant head injury, Parkinson's disease, current or prior excess use of alcohol that, in the investigator's judgment, has caused or significantly contributed to the subject's cognitive decline, or primary psychiatric disorders (e.g., schizophrenia or bipolar affective disorder).
- Unstable medical conditions which are likely to impact subject's ability to complete the trial and which are likely to confound AE assessment. These include, but are not limited to, uncontrolled hypertension, uncontrolled diabetes, and cancer within past the 2 years. Exceptions include prostate cancer in-situ and local basal and squamous cell skin cancers.
- Chronic use of systemic or inhaled steroids (use of topical steroids is acceptable).
- Other concomitant medications that, in the Investigator's judgment, impair cognition and/or confound efficacy assessments.
- Women of child-bearing potential are excluded (e.g., women who have not been post-menopausal for at least 2 years or are not surgically sterile).
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 |
|---|---|---|
| RPh201RPh201 is a well-defined extract from a botanical source | Drug | RPh201 |
| PlaceboAlso: Cottonseed oilInactive placebo consisting of the therapeutic vehicle | Other | Placebo |
Primary outcome
Change in (Alzheimer disease assessment scale) ADAS-Cog score between Baseline and Month 6
Time frame: Month 6
The ADAS-Cog is an established general cognitive measure scaled used in clinical trials of AD. The ADAS-Cog assesses multiple performance and cognitive domains including memory, language, praxis, and orientation. Test responses are scored using summed error points where 0 represents no errors and 70 represents errors on all items; higher scores indicate greater cognitive impairment.
Change in CDR-SB score between Baseline and Month 6
Time frame: Month 6
The CDR is a global clinical scale with established diagnostic and severity-ranking utility widely used in clinical trials yielding global and sum of boxes scores (CDR-SB). The CDR global score is used in AD trials as a global measure of disease severity. The CDR is rated based on subject and informant input. The CDR assess three domains of cognition (memory, orientation, judgment/problem solving) and three domains of function (community affairs, home/hobbies, personal care) using semi- structured interviews of both the study subject and a companion/informant carried out by a trained rater and scored using a standard methodology. Each domain is rated on a 5-point scale of functioning as follows: (0) no impairment; (0.5) questionable impairment; (1) mild impairment; (2) moderate impairment; (3) severe impairment (personal care is scored on a 4-point scale without a 0.5 rating available). Higher scores indicate greater impairment.
AEs at Month 6
Time frame: Month 6
12-lead ECG at Month 6
Time frame: Month 6
Clinical Laboratory Assessments - (blood and urine) at at Month 6
Time frame: Month 6
Chemistry: alkaline phosphatase, albumin, blood urea nitrogen, calcium, chloride, creatinine, glucose (random), inorganic phosphorus, potassium, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transpeptidase, lactate dehydrogenase, sodium, direct bilirubin, total bilirubin, total protein, amylase, uric acid Hematology: haemoglobin, hematocrit, red blood cell count, white blood cell (WBC) count, WBC differential (absolute counts), numerical platelet count Urinalysis: specific gravity, pH, ketones, glucose, nitrite, blood, leukocyte esterase, protein, urobilinogen, bilirubin If nitrite, blood, or protein tests are positive, a microscopic examination will be performed
Vital Signs
Time frame: Month 6
Vital signs consist of tympanic temperature, respiratory rate, blood pressure (systolic and diastolic blood pressure, mmHg), and pulse (bpm) after at least 3 minutes rest. Blood pressure will be measured in a sitting or semi-reclined seated position. Weight and height will be captured at Screening and weight will be captured at all other visits where this assessment is performed.
19 secondary outcomes
Change from Baseline on ADAS-Cog total scores at Month 3
Time frame: Months 3
Change from Baseline on ADAS-Cog total scores at Month 5
Time frame: Month 5
Change from Baseline on ADAS-Cog total scores at Month 12
Time frame: Month 12
Change from Baseline on CDR-SB total scores at Month 3
Time frame: Month 3
Change from Baseline on CDR-SB total scores at Month 5
Time frame: Month 5
Change from Baseline on CDR-SB total scores at Month 12
Time frame: Month 12
Change from Baseline in ADCS-ADL total score at Month 3
Time frame: Month 3
Change from Baseline in ADCS-ADL total score at Months 12
Time frame: Month 12
Change from Baseline in NPI total score at Month 3
Time frame: Month 3
Change from Baseline in NPI total score at Month 6
Time frame: Month 6
Change from Baseline in NPI total score at Month 12
Time frame: Month 12
Change from Baseline in the MMSE at Month 3
Time frame: Month 3
Change from Baseline in the MMSE at Month 6
Time frame: Month 6
Change from Baseline in the MMSE at Month 12
Time frame: Month 12
AEs at Month 12
Time frame: Month 12
Clinically significant changes in vital signs at Month 12
Time frame: Month 12
12-lead ECG at Month 12
Time frame: Month 12
Clinical Laboratory Assessments - (blood and urine) at Month 12
Time frame: Month 12
Vital Signs
Time frame: Month 12
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 30 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
Sharon Cohen, MD principal investigator
Toronto Memory Program
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RPh201 in people with Mild to Moderate Dementia Due to Alzheimer's Disease and With or Without Coexisting Cerebrovascular Disease, run by Regenera Pharma Ltd at 5 sites 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 12 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 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in (Alzheimer disease assessment scale) ADAS-Cog score between Baseline and Month 6 (time frame: Month 6). The study lists 6 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 30 Apr 2020.