A Study Investigating the Effectiveness of a LifeSeasons NeuroQ Supplement With Lifestyle Changes to Improve Cognitive Function in Healthy Adults Who Have One or More Risk Factors for Cognitive Decline

Last updated: March 1, 2021
Sponsor: LifeSeasons Inc.
Overall Status: Completed

Phase

N/A

Condition

Mental Disability

Memory Loss

Dementia

Treatment

N/A

Clinical Study ID

NCT04149639
19IPHL
  • Ages > 45
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The objective of this study is to evaluate the efficacy of a NeuroQ supplement designed by Dr. Bredesen to complement his Lifestyle modification protocol. Eligible participants will be expected to consume the NeuroQ supplement and are recommended to make lifestyle changes based on Dr. Bredesen's protocol. Forty participants are expected to enroll into the study, completing study assessments at check in visits days 30 and 60, and at the end of study visit on day 90. A brief follow up phone call will be conducted approximately 30 days after study completion to ask participants if they have continued using the lifestyle changes and if they have purchased and continued to consume the NeuroQ supplement.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Males and females 45 years of age or older with one or more of the following riskfactors for cognitive decline:
  • Self-reported genetic risk factor of Alzheimer's Disease or dementia as confirmedby Apolipoprotein 4 genetic testing
  • Self-reported family history of Alzheimer's Disease or dementia in a first-degreerelative
  • Self-reported lifestyle risk factor: sedentary lifestyle; poor dietary habits (e.g. insufficient consumption of fruits and vegetables for necessary nutrients);poor social support network (e.g. majority of evenings and weekends are spent inisolation); poor stress management skills (e.g. binge eating habits or performingharmful activities during periods of stress); poor sleep habits; metabolicsyndrome
  • Exception: Individuals 60 years of age or older may be enrolled without any ofthe above risk factors.
  1. BMI between 18.5 and 32.5 kg/m2
  2. Female participants are not of child-bearing potential, defined as females who haveundergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy,bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal (natural or surgically) for at least 1 year prior to screening or, Females of child-bearing potential must have a negative baseline urine pregnancy test andagree to use a medically approved method of birth control for the duration of the study.All hormonal birth control must have been in use for a minimum of three months. Acceptablemethods of birth control include:
  • Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
  • Double-barrier method
  • Intrauterine devices
  • Non-heterosexual lifestyle or agrees to use contraception if planning on changing toheterosexual partner(s)
  • Vasectomy of partner at least 6 months prior to screening 4. Self-reported asnon-smoker or user of any nicotine-containing products 5. Absence of dementia or othersignificant cognitive impairment as assessed by Mini Mental State Exam-2 StandardVersion (MMSE-2) score ≥24 6. Participants who test between the 24-75th percentile inthe in one or more domains in the NCI 7. Low frequency of depressed mood as assessedby PHQ-9 score of 4 or less 8. Agree to avoid caffeine consumption 24 hours prior toin-clinic visits 9. Agree to avoid alcohol consumption 24 hours prior to in-clinicvisits 10. Healthy as determined by medical history and laboratory results as assessedby QI

Exclusion

Exclusion Criteria:

  1. Women who are pregnant, breast feeding, or planning to become pregnant during thetrial
  2. Allergy, sensitivity, or intolerance to the investigational product's (IP) active orinactive ingredients
  3. Self-reported confirmation of neuropsychological condition and/or cognitive impairmentthat, in the QI's opinion, could interfere with study participation. For e.g.: • Schizophrenia, bipolar disorder, post-traumatic stress disorder, brain injury,neurodegenerative disease, infections, insomnia
  4. Participants with vitamin deficiencies affecting cognition:
  • Magnesium
  • Cobalamin (Vitamin B12)
  • Folate below the normal clinical ranges, as assessed by the QI
  1. Participants who test below the 24th percentile or above the 75th percentile in alldomains in the NCI.
  2. Current use of prescribed medications listed in Section 8.3.1.
  3. Current use of over-the-counter medications, supplements, foods and/or drinks listedas concomitant medications.
  4. Unstable metabolic disease or chronic diseases as assessed by the QI
  5. Unstable hypertension. Treatment on a stable dose of medication for at least 3 monthswill be considered by the QI
  6. Type II diabetes. Treatment on a stable dose of medication may be considered by the QIon a case by case basis
  7. Significant cardiovascular event in the past 6 months. Participants with nosignificant cardiovascular event on stable medication may be included after assessmentby the QI on a case by case basis
  8. Major surgery in the past 3 months or individuals who have planned surgery during thecourse of the trial. Participants with minor surgery will be considered on acase-by-case basis by the QI
  9. Cancer, except skin cancers completely excised with no chemotherapy or radiation witha follow up that is negative. Volunteers with cancer in full remission for more thanfive years after diagnosis are acceptable
  10. Individuals who are immune-compromised
  11. Verbal confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis
  12. History of or current diagnosis with kidney and/or liver diseases as assessed by theQI on a case-by-case basis, with the exception of history of kidney stones symptomfree for 6 months
  13. Verbal confirmation of current or pre-existing thyroid condition. Treatment on astable dose of medication for at least 3 months will be considered by the QI
  14. Current or history of any significant diseases of the gastrointestinal tract
  15. Verbal confirmation of blood/bleeding disorders
  16. Self-reported chronic use of cannabinoid products or currently taking medicalcannabinoid products containing >0.3% tetrahydrocannabinol
  17. Alcohol or drug abuse within the last 12 months
  18. High alcohol intake (>2 drinks per day or >10 standard drinks per week)
  19. Blood donation 30 days prior to screening, during the study, or a planned donationwithin 30-days of the last study visit
  20. Participation in other clinical research trials 30 days prior to screening
  21. Individuals who are unable to give informed consent
  22. Any other active or unstable medical condition, that, in the opinion of the QI, mayadversely affect the participant's ability to complete the study or its measures orpose significant risk to the participant

Study Design

Total Participants: 40
Study Start date:
November 08, 2019
Estimated Completion Date:
July 07, 2020

Connect with a study center

  • Kapoor Medical Center

    Studio City, California 91604
    United States

    Site Not Available

  • LifeSeasons Medical Center

    Flower Mound, Texas 75077
    United States

    Site Not Available

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