Alzheimer DiseasePhase 3NCT00743743
Pilot Study of the Effects of Resveratrol Supplement in Mild-to-moderate Alzheimer's Disease
A Phase 3 study testing Longevinex brand resveratrol supplement in people with Alzheimer Disease, run by Medical College of Wisconsin.
Trial summary
Objective: To determine the effects of resveratrol extract given in a 215 mg dose in a daily supplement currently available over the counter, on cognitive and global functioning in patients with mild to moderate AD on standard therapy. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Longevinex brand resveratrol supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Dec 2010
- Phase
- Phase 3
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Male or female subject with a clinical diagnosis of probable Alzheimer's disease in accordance with NINCDS-ADRDA criteria (Appendix 2).
- Subject has mild to moderate Alzheimer's disease as defined by a MMSE score 10 to 27 inclusive at Screening.
- Hachinski Ischemia Score ≤ at Screening (See Appendix 3).
- Age ≥50 and ≤90 years.
- At least 6 months of ongoing acetylcholinesterase inhibitor therapy for Alzheimer's disease, with stable dosing for at least the last 2 months (and with no intent to change for the duration of the study).
Show all 14Show fewer
- Current use of medication is in accordance with the criteria listed in Table 2 (Permitted Medications, Section 8.1 ).
- Female subjects must be post-menopausal (i.e. >24 weeks without menstrual period), surgically sterile, or agree to use adequate method of contraception for the duration of the study. Female subjects who are pre-menopausal or who have been post-menopausal for <2 years must undertake pregnancy testing (urine test) at Visit 1, which must be negative.
- Brain CT or MRI scan performed within the past 12 months or at Screening, showing no evidence of any other potential cause of dementia other than Alzheimer's disease.
- Neurological exam without focal changes (excluding changes attributable to AD or peripheral trauma).
- Subject has the ability to comply with procedures for cognitive and other testing.
- Subject lives with (or has substantial periods of contact with) a regular caregiver who is willing to attend all visits, oversee the subject's compliance with protocol-specified procedures and study medication, and report on subject's status.
- Subject has provided full written informed consent prior to the performance of any protocol-specified procedure; or if unable to provide informed consent due to cognitive status, full written informed consent on behalf of the subject has been provided by a legally acceptable representative.
- Caregiver has provided full written informed consent on his/her own behalf prior to the performance of any protocol-specified procedure.
Who cannot join
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Diagnosis of possible, probably, or definite vascular dementia in accordance with NINDS-AIREN criteria (Appendix 4).
- History or evidence of any other CNS disorder that could be interpreted as a cause of dementia; e.g. cerebrovascular disease (stroke, hemorrhage), structural abnormality, epilepsy, infectious or inflammatory/demyelinating CNS conditions, Parkinson's disease.
- Evidence of the following disorders: current vitamin B12 deficiency, positive syphilis serology, or active thyroid dysfunction (particularly that suggestive of hypothyroidism), including abnormally high or low serum levels of thyroid stimulating hormone (TSH) that is clinically significant in the opinion of the investigator.
- History of Type 1 diabetes mellitus or secondary diabetes mellitus.
- Type 2 diabetes mellitus where the subject is being treated with insulin, a PPARγ agonist, or an insulin secretagogue (e.g. a sulfonylurea or glitinide).
Show all 21Show fewer
- Any patient with an HbA1c≥8.5%. (See Section 6.3.8.4 for Safety Measures for Enrolled Subjects with Type 2 Diabetes Mellitus.)
- History or clinical/investigational evidence of congestive heart failure defined by the New York Heart Association criteria (Class I to IV cardiac status; Appendix 5).
- History of cardiovascular event within the last 6 months (i.e. intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome [non Q-wave myocardial infarction, Q-wave myocardial infarction, unstable angina] or significant arrhythmia; or major intervention (e.g. cardiac surgery or angiography plus stenting) scheduled).
- History of significant psychiatric illness such as schizophrenia or bipolar affective disorder that in the opinion of the Investigator would interfere with participation in the study, major depressive disorder (according to DSM-IV) in the past year, or current active depression requiring treatment.
- History or presence of gastro-intestinal, hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs, ,or any other clinically relevant abnormality, medical or psychiatric condition, which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
- Clinically significant peripheral edema at the time of screening.
- Current or recent drug or alcohol abuse or dependence (defined by DSM-IV criteria for substance-related disorders), or recent or remote history of the same if that could be a contributing factor to the dementia.
- Systolic blood pressure >165 or <90 mmHg or diastolic blood pressure >95 or <60 mmHg at the time of screening.
- Clinically significant anemia (i.e. hemoglobin >11 g/dL for males or <10 g/dL for females) or presence of hemoglobinopathies which would prevent accurate assessment of HbA1c.
- Abnormal kidney function tests (>1.5 times the upper limit of normal (ULN)).
- ALT, AST, or alkaline phosphatase values >2.5 times the ULN, total bilirubin values >1.5 times the ULN, or history of severe hepatobiliary disease (e.g. hepatitis B or C, or cirrhosis, Child-Pugh Class B/C).
- History of bone marrow transplant.
- Subject is unable (with assistance, if appropriate) to take study medication as prescribed throughout the study or is at risk of non-compliance with study medication or procedures.
- Subject is an immediate family member or employee of the participating Investigator, of any of the participating site staff.
- -
About this study
Official title: Randomized, Placebo-controlled Clinical Trial of Resveratrol Supplement Effects on Cognition, Function and Behavior in Patients With Mild-to-moderate Alzheimer's Disease
Objective: To determine the effects of resveratrol extract given in a 215 mg dose in a daily supplement currently available over the counter, on cognitive and global functioning in patients with mild to moderate AD on standard therapy.
Read the detailed description
Background: Many animal and in vitro studies have shown that resveratrol, a naturally occurring polyphenol found in red wine, can increase cognition, reduce neural degeneration, promote clearance of amyloid-beta peptides, and alter aging mechanisms. Therefore, resveratrol may reduce the symptoms of Alzheimer's disease (AD) and possibly its pathology. Objective: A pilot study to determine the effects of resveratrol on cognitive, behavioral and global functioning in patients with mild-to-moderate AD on standard therapy. Design: Randomized, double-blind, placebo-controlled clinical trial. Participants: 50 patients with mild-moderate Alzheimer's disease (AD) defined as a Mini-Mental State Exam (MMSE) between 10-27 will be enrolled in the study. Patients must have an established diagnosis of AD by NINCDS diagnostic criteria, be on stable dose of cognitive enhancing medications (cholinesterase inhibitor and/or NMDA receptor antagonist) Screening/Enrollment: Institutional Review Board approval will be obtained. The chart review and the enrollment discussion will be carried out by a non-physician member of the research team. Participants will be screened and randomized until a total of 50 eligible patients, 25 in each arm are obtained.
- Conditions
- Alzheimer Disease
- Being tested
- Longevinex brand resveratrol supplement, placebo
- Keywords
- dementia, Alzheimer disease, cognition, function, behavior, treatment
- Medical subject headings
- Alzheimer Disease, Dementia, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Longevinex brand resveratrol supplementDietary supplement
Also called Longevinex brand to manufacture the active capsules and placebo capsules for the purposes of this study.
1 capsule daily for 52 weeks containing 215 mg of resveratrol active ingredient
placeboDietary supplement
Also called Longevinex brand to manufacture placebo capsules to be identical to active agent capsules
1 capsule of placebo daily for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | receive 1 Longevinex brand capsule daily containing 215 mg of resveratrol active ingredient Receives: Dietary Supplement: Longevinex brand resveratrol supplement |
| 2 | Placebo comparator | Receive 1 capsule daily for 52 weeks containing placebo for comparison to experimental arm Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognition
Measured: 52 weeks
Secondary outcomes (2)
function
Measured: 52 weeks
behavior
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionJun 2010 (estimated)
- Study completionDec 2010 (estimated)
Why it stopped: PI has left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diana R Kerwin, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743743
- Sponsor's protocol ID
- Resveratrol2008
- Status last verified
- Aug 2015
- First submitted
- 27 Aug 2008
- Last updated
- 24 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-controlled Clinical Trial of Resveratrol Supplement Effects on Cognition, Function and Behavior in Patients With Mild-to-moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00743743
- Acronym / sponsor ID
- Resveratrol2008
- Conditions
- Alzheimer Disease
- Keywords
- dementia, Alzheimer disease, cognition, function, behavior, treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI has left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 29 Aug 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.
Objective: To determine the effects of resveratrol extract given in a 215 mg dose in a daily supplement currently available over the counter, on cognitive and global functioning in patients with mild to moderate AD on standard therapy.
Detailed description
Background: Many animal and in vitro studies have shown that resveratrol, a naturally occurring polyphenol found in red wine, can increase cognition, reduce neural degeneration, promote clearance of amyloid-beta peptides, and alter aging mechanisms. Therefore, resveratrol may reduce the symptoms of Alzheimer's disease (AD) and possibly its pathology. Objective: A pilot study to determine the effects of resveratrol on cognitive, behavioral and global functioning in patients with mild-to-moderate AD on standard therapy. Design: Randomized, double-blind, placebo-controlled clinical trial. Participants: 50 patients with mild-moderate Alzheimer's disease (AD) defined as a Mini-Mental State Exam (MMSE) between 10-27 will be enrolled in the study. Patients must have an established diagnosis of AD by NINCDS diagnostic criteria, be on stable dose of cognitive enhancing medications (cholinesterase inhibitor and/or NMDA receptor antagonist) Screening/Enrollment: Institutional Review Board approval will be obtained. The chart review and the enrollment discussion will be carried out by a non-physician member of the research team. Participants will be screened and randomized until a total of 50 eligible patients, 25 in each arm are obtained.
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 |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Longevinex brand resveratrol supplementreceive 1 Longevinex brand capsule daily containing 215 mg of resveratrol active ingredient |
| 2 | Placebo comparator | Dietary Supplement: placeboReceive 1 capsule daily for 52 weeks containing placebo for comparison to experimental arm |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Male or female subject with a clinical diagnosis of probable Alzheimer's disease in accordance with NINCDS-ADRDA criteria (Appendix 2).
- Subject has mild to moderate Alzheimer's disease as defined by a MMSE score 10 to 27 inclusive at Screening.
- Hachinski Ischemia Score ≤ at Screening (See Appendix 3).
- Age ≥50 and ≤90 years.
Key exclusion criteria (21 listed)
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Diagnosis of possible, probably, or definite vascular dementia in accordance with NINDS-AIREN criteria (Appendix 4).
- History or evidence of any other CNS disorder that could be interpreted as a cause of dementia; e.g. cerebrovascular disease (stroke, hemorrhage), structural abnormality, epilepsy, infectious or inflammatory/demyelinating CNS conditions, Parkinson's disease.
- Evidence of the following disorders: current vitamin B12 deficiency, positive syphilis serology, or active thyroid dysfunction (particularly that suggestive of hypothyroidism), including abnormally high or low serum levels of thyroid stimulating hormone (TSH) that is clinically significant in the opinion of the investigator.
- History of Type 1 diabetes mellitus or secondary diabetes mellitus.
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 |
|---|---|---|
| Longevinex brand resveratrol supplementAlso: Longevinex brand to manufacture the active capsules and placebo capsules for the purposes of this study.1 capsule daily for 52 weeks containing 215 mg of resveratrol active ingredient | Dietary supplement | 1 |
| placeboAlso: Longevinex brand to manufacture placebo capsules to be identical to active agent capsules1 capsule of placebo daily for 52 weeks | Dietary supplement | 2 |
Primary outcome
cognition
Time frame: 52 weeks
2 secondary outcomes
function
Time frame: 52 weeks
behavior
Time frame: 52 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2015.
Related trials for Alzheimer 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.
Diana R Kerwin, MD principal investigator
Medical College of Wisconsin
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Longevinex brand resveratrol supplement in people with Alzheimer Disease, run by Medical College of Wisconsin.
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 14 inclusion and 21 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: withdrawn, as of the sponsor's last update on 24 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
cognition (time frame: 52 weeks). 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 24 Aug 2015.