Clinical trial NCT04149639: 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
Official title: An Open-label Study to Investigate the Effectiveness of a LifeSeasons NeuroQ Supplement in Addition to Four Bredesen Recommended Lifestyle Changes to Improve Cognitive Function in Healthy Adults Who Have One or More Risk Factors for Cognitive Decline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: NeuroQ
Dr. Bredesen
PreCODE protocol
ReCODE method
cognitive decline
The End of Alzheimer's
cognitive support
cognitive health
Lead sponsor: LifeSeasons Inc.
Sponsor class: INDUSTRY
Collaborators: name: KGK Science Inc.
First posted: 2019-11-04
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label design
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. BMI between 18.5 and 32.5 kg/m2
3. 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

Exclusion Criteria:

1. Women who are pregnant, breast feeding, or planning to become pregnant during the trial
2. Allergy, sensitivity, or intolerance to the investigational product's (IP) active or inactive ingredients
3. 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
4. Participants with vitamin deficiencies affecting cognition:

   * Magnesium
   * Cobalamin (Vitamin B12)
   * Folate below the normal clinical ranges, as assessed by the QI
5. Participants who test below the 24th percentile or above the 75th percentile in all domains in the NCI.
6. Current use of prescribed medications listed in Section 8.3.1.
7. Current use of over-the-counter medications, supplements, foods and/or drinks listed as concomitant medications.
8. Unstable metabolic disease or chronic diseases as assessed by the QI
9. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
10. Type II diabetes. Treatment on a stable dose of medication may be considered by the QI on a case by case basis
11. 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
12. Major surgery in the past 3 months or individuals who have planned surgery during the course of the trial. Participants with minor surgery will be considered on a case-by-case basis by the QI
13. Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
14. Individuals who are immune-compromised
15. Verbal confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis
16. History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones symptom free for 6 months
17. Verbal confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
18. Current or history of any significant diseases of the gastrointestinal tract
19. Verbal confirmation of blood/bleeding disorders
20. Self-reported chronic use of cannabinoid products or currently taking medical cannabinoid products containing \>0.3% tetrahydrocannabinol
21. Alcohol or drug abuse within the last 12 months
22. High alcohol intake (\>2 drinks per day or \>10 standard drinks per week)
23. Blood donation 30 days prior to screening, during the study, or a planned donation within 30-days of the last study visit
24. Participation in other clinical research trials 30 days prior to screening
25. Individuals who are unable to give informed consent
26. Any other active or unstable medical condition, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant

Primary outcomes:
measure: 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.
timeFrame: 90-135 days
Secondary outcomes:
measure: Change in Neurocognitive Index (NCI) individual domains from screening to end-of study in participants who are fully compliant with supplementation and lifestyle modification
timeFrame: 90-135 days
measure: Change in Neurocognitive Index (NCI) individual domains from screening to end-of-study in participants who are compliant with supplementation only
timeFrame: 90-135 days
measure: Change in Neurocognitive Index (NCI) individual domains from screening to end-of-study in participants who are compliant with lifestyle modification only
timeFrame: 90-135 days
measure: Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - composite memory from screening to end-of-study
timeFrame: 90-135 days
measure: Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - verbal memory from screening to end-of-study
timeFrame: 90-135 days
measure: Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - visual memory from screening to end-of-study
timeFrame: 90-135 days
measure: Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - psychomotor speed from screening to end-of-study
timeFrame: 90-135 days
measure: Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - reaction time from screening to end-of-study
timeFrame: 90-135 days
measure: Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - complex attention from screening to end-of-study
timeFrame: 90-135 days
measure: Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - cognitive flexibility from screening to end-of-study
timeFrame: 90-135 days
measure: Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - processing speed from screening to end-of-study
timeFrame: 90-135 days
measure: Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - executive function from screening to end-of-study
timeFrame: 90-135 days
measure: Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - simple attention from screening to end-of-study
timeFrame: 90-135 days
measure: Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - motor speed from screening to end-of-study
timeFrame: 90-135 days
measure: Number of participants motivated to make lasting changes to their lifestyle at end-of-study.
timeFrame: 90-120 days
measure: Change in Mini Mental State Exam Version 2 (MMSE-2) score from screening to end-of study.
timeFrame: 90-135 days
Other outcomes:
measure: Incidence of pre-emergent and post-emergent adverse events following 30-day, supplementation.
timeFrame: 30 days
measure: Incidence of pre-emergent and post-emergent adverse events following 60-day, supplementation.
timeFrame: 60 days
measure: Incidence of pre-emergent and post-emergent adverse events following 90-day, supplementation.
timeFrame: 90 days
measure: Change in systolic blood pressure following 30-day supplementation
timeFrame: 30 days
measure: Change in systolic blood pressure following 60-day supplementation
timeFrame: 60 days
measure: Change in systolic blood pressure following 90-day supplementation
timeFrame: 90 days
measure: Change in diastolic blood pressure following 30-day supplementation
timeFrame: 30 days
measure: Change in diastolic blood pressure following 60-day supplementation
timeFrame: 60 days
measure: Change in diastolic blood pressure following 90-day supplementation
timeFrame: 90 days
measure: Change in heart rate following 30-day supplementation
timeFrame: 30 days
measure: Change in heart rate following 60-day supplementation
timeFrame: 60 days
measure: Change in heart rate following 90-day supplementation
timeFrame: 90 days
measure: Change in CMP following 90-day supplementation
timeFrame: 90 days
measure: Change in complete blood count following 90-day supplementation
timeFrame: 90 days
measure: Change in neutrophil levels in the blood following 90-day supplementation
timeFrame: 90 days
measure: Change in lymphocyte blood levels following 90-day supplementation
timeFrame: 90 days
measure: Change in monocyte blood levels following 90-day supplementation
timeFrame: 90 days
measure: Change in eosinophil blood levels following 90-day supplementation
timeFrame: 90 days
measure: Change in basophil blood levels following 90-day supplementation
timeFrame: 90 days
measure: Change in red blood cell (RBC) count following 90-day supplementation
timeFrame: 90 days
measure: Change in hemoglobin levels in the blood following 90-day supplementation
timeFrame: 90 days
measure: Change in hematocrit levels in the blood following 90-day supplementation
timeFrame: 90 days
measure: Change in platelet count following 90-day supplementation
timeFrame: 90 days
measure: Change in mean corpuscular volume (MCV) following 90-day supplementation
timeFrame: 90 days
measure: Change in mean corpuscular hemoglobin (MCH) following 90-day supplementation
timeFrame: 90 days
measure: Change in mean corpuscular hemoglobin concentration (MCHC) following 90-day supplementation
timeFrame: 90 days
measure: Change in red cell distribution width (RDW) following 90-day supplementation
timeFrame: 90 days
measure: Difference in brain activity as measured by quantitative electroencephalography (qEEG) from baseline to end-of-study in 10 participants.
timeFrame: 90 days
Locations:
city: Studio City
country: United States
facility: Kapoor Medical Center
state: California
city: Flower Mound
country: United States
facility: LifeSeasons Medical Center
state: Texas
Study officials:
affiliation: LifeSeasons Inc.
name: Jamie Langston
role: STUDY_DIRECTOR
References: