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

NCT04149639 | Completed

• 1 other identifier: 19IPHL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Healthy

Keywords

NeuroQ; Dr. Bredesen; PreCODE protocol; ReCODE method; cognitive decline; The End of Alzheimer's; cognitive support; cognitive health

Outcome Measures

Primary Outcomes (1)

• Change in cognition as assessed by change in Neurocognitive Index (NCI) score from CNS-Vital Signs (CNS-VS) panel from screening to end-of-study.

  The Neurocognitive index is an average score derived from the domain scores or a general assessment of the overall neurocognitive status of the participant. The scores range from less than 70 (very low) to above 110 (above average). A higher score means higher neurocognitive function and higher capacity.

  90-135 days

Secondary Outcomes (16)

• Change in Neurocognitive Index (NCI) individual domains from screening to end-of study in participants who are fully compliant with supplementation and lifestyle modification

  90-135 days

• Change in Neurocognitive Index (NCI) individual domains from screening to end-of-study in participants who are compliant with supplementation only

  90-135 days

• Change in Neurocognitive Index (NCI) individual domains from screening to end-of-study in participants who are compliant with lifestyle modification only

  90-135 days

• Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - composite memory from screening to end-of-study

  90-135 days

• Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - verbal memory from screening to end-of-study

  90-135 days

Other Outcomes (28)

• Incidence of pre-emergent and post-emergent adverse events following 30-day, supplementation.

  30 days

• Incidence of pre-emergent and post-emergent adverse events following 60-day, supplementation.

  60 days

• Incidence of pre-emergent and post-emergent adverse events following 90-day, supplementation.

  90 days

Study Arms (1)

NeuroQ

EXPERIMENTAL

Directions: take 2 capsules at the same time daily

Dietary Supplement: NeuroQ

Interventions

NeuroQ DIETARY_SUPPLEMENT

Supplement includes phosphatidylserine, coffee fruit, curcumin, ginkgo, gotu kola, and propolis active ingredients inside a veggie capsule.

NeuroQ

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females 45 years of age or older with one or more of the following risk factors for cognitive decline:
• Self-reported genetic risk factor of Alzheimer's Disease or dementia as confirmed by Apolipoprotein 4 genetic testing
• Self-reported family history of Alzheimer's Disease or dementia in a first-degree relative
• 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 in isolation); poor stress management skills (e.g. binge eating habits or performing harmful activities during periods of stress); poor sleep habits; metabolic syndrome
• Exception: Individuals 60 years of age or older may be enrolled without any of the above risk factors.
• BMI between 18.5 and 32.5 kg/m2
• Female participants are not of child-bearing potential, defined as females who have undergone 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 and agree 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. Acceptable methods 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 to heterosexual partner(s)
• Vasectomy of partner at least 6 months prior to screening 4. Self-reported as non-smoker or user of any nicotine-containing products 5. Absence of dementia or other significant cognitive impairment as assessed by Mini Mental State Exam-2 Standard Version (MMSE-2) score ≥24 6. Participants who test between the 24-75th percentile in the in one or more domains in the NCI 7. Low frequency of depressed mood as assessed by PHQ-9 score of 4 or less 8. Agree to avoid caffeine consumption 24 hours prior to in-clinic visits 9. Agree to avoid alcohol consumption 24 hours prior to in-clinic visits 10. Healthy as determined by medical history and laboratory results as assessed by QI

You may not qualify if:

• Women who are pregnant, breast feeding, or planning to become pregnant during the trial
• Allergy, sensitivity, or intolerance to the investigational product's (IP) active or inactive ingredients
• Self-reported confirmation of neuropsychological condition and/or cognitive impairment that, 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 all domains 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 listed as 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 months will be considered by the QI
• Type II diabetes. Treatment on a stable dose of medication may be considered by the QI on a case by case basis
• Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case by case basis

Sponsors & Collaborators

• LifeSeasons Inc.: lead
• KGK Science Inc.: collaborator

Study Sites (2)

Kapoor Medical Center

Studio City, California, 91604, United States

Location

LifeSeasons Medical Center

Flower Mound, Texas, 75077, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jamie Langston

  LifeSeasons Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label design

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 4, 2019
• Study Start: November 8, 2019
• Primary Completion: July 7, 2020
• Study Completion: July 7, 2020
• Last Updated: March 2, 2021

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)