Pilot Study of the Effects of Resveratrol Supplement in Mild-to-moderate Alzheimer's Disease

NCT00743743 | Withdrawn Phase 3 DMC

• 1 other identifier: Resveratrol2008
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Alzheimer Disease

Keywords

dementia; Alzheimer disease; cognition; function; behavior; treatment

Outcome Measures

Primary Outcomes (1)

• cognition

  52 weeks

Secondary Outcomes (2)

• function

  52 weeks

• behavior

  52 weeks

Study Arms (2)

1

EXPERIMENTAL

receive 1 Longevinex brand capsule daily containing 215 mg of resveratrol active ingredient

Dietary Supplement: Longevinex brand resveratrol supplement

2

PLACEBO COMPARATOR

Receive 1 capsule daily for 52 weeks containing placebo for comparison to experimental arm

Dietary Supplement: placebo

Interventions

Longevinex brand resveratrol supplement DIETARY_SUPPLEMENT

1 capsule daily for 52 weeks containing 215 mg of resveratrol active ingredient

Also known as: Longevinex brand to manufacture the active capsules and placebo capsules for the purposes of this study.

1

placebo DIETARY_SUPPLEMENT

1 capsule of placebo daily for 52 weeks

Also known as: Longevinex brand to manufacture placebo capsules to be identical to active agent capsules

2

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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).
• 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.
• 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).

Sponsors & Collaborators

• Medical College of Wisconsin: lead

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Behavior

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Diana R Kerwin, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2008
• First Posted: August 29, 2008
• Study Start: September 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 24, 2015

Record last verified: 2015-08