Last updated: March 1, 2021
Sponsor: LifeSeasons Inc.
Overall Status: Completed
Phase
N/A
Condition
Mental Disability
Memory Loss
Dementia
Treatment
N/AClinical Study ID
NCT04149639
19IPHL
Ages > 45 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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.
- BMI between 18.5 and 32.5 kg/m2
- 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:
- Women who are pregnant, breast feeding, or planning to become pregnant during thetrial
- Allergy, sensitivity, or intolerance to the investigational product's (IP) active orinactive ingredients
- 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
- Participants with vitamin deficiencies affecting cognition:
- Magnesium
- Cobalamin (Vitamin B12)
- Folate below the normal clinical ranges, as assessed by the QI
- Participants who test below the 24th percentile or above the 75th percentile in alldomains in the NCI.
- Current use of prescribed medications listed in Section 8.3.1.
- Current use of over-the-counter medications, supplements, foods and/or drinks listedas concomitant medications.
- Unstable metabolic disease or chronic diseases as assessed by the QI
- Unstable hypertension. Treatment on a stable dose of medication for at least 3 monthswill be considered by the QI
- Type II diabetes. Treatment on a stable dose of medication may be considered by the QIon a case by case basis
- 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
- 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
- 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
- Individuals who are immune-compromised
- Verbal confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis
- 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
- 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
- Current or history of any significant diseases of the gastrointestinal tract
- Verbal confirmation of blood/bleeding disorders
- Self-reported chronic use of cannabinoid products or currently taking medicalcannabinoid products containing >0.3% tetrahydrocannabinol
- Alcohol or drug abuse within the last 12 months
- High alcohol intake (>2 drinks per day or >10 standard drinks per week)
- Blood donation 30 days prior to screening, during the study, or a planned donationwithin 30-days of the last study visit
- Participation in other clinical research trials 30 days prior to screening
- Individuals who are unable to give informed consent
- 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 StatesSite Not Available
LifeSeasons Medical Center
Flower Mound, Texas 75077
United StatesSite Not Available

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