An Open-label, Exploratory Study to Investigate the Efficacy of BDNF Essentials® on Cognition

NCT04860778 | Completed Phase 1

• 1 other identifier: 21BCHR
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this open-label, exploratory study is to investigate the efficacy of BDNF Essentials® on cognition in a healthy adult population with self-reported memory complaints. As there is a dearth of available literature on BDNF in this study population, the current study is designed to understand the role of BDNF to inform potential future studies.

Conditions

Cognitive Change

Outcome Measures

Primary Outcomes (4)

• Change in cognitive function

  Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for memory

  baseline to day 84

• Change in cognitive function

  Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for attention

  baseline to day 84

• Change in cognitive function

  Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for processing speed

  baseline to day 84

• Change in cognitive function

  Assessed by plasma Brain-Derived Neurotrophic Factor (BDNF) levels

  baseline to day 84

Secondary Outcomes (20)

• Change in plasma BDNF levels

  baseline to day 28

• Change in plasma BDNF levels

  baseline to day 56

• Change in memory

  baseline to day 28

• Change in memory

  baseline to day 56

• Change in attention

  baseline to day 28

Other Outcomes (28)

• Change in body weight

  baseline to day 84

• Incidence of adverse events

  screening to day 84

• Change in systolic blood pressure

  baseline to day 84

Study Arms (1)

BDNF Essentials

EXPERIMENTAL

A proprietary blend of botanical extracts and isolates.

Dietary Supplement: BDNF Essentials

Interventions

BDNF Essentials DIETARY_SUPPLEMENT

Participants will take two capsules, twice daily with water for 84 days.

BDNF Essentials

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 and older
• Waist circumference \< 102 cm (40 inches) in men and \< 88 cm (35 inches) in women
• Female participant is 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 for at least 1 year prior to enrollment
• 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 enrollment
• A score of ≥ 24 on the Mini-Mental State Examination (MMSE 2)
• Self-reported memory complaints as assessed by the revised Everyday Memory Questionnaire (EMQ) (with a score of ≥ 32)
• Agrees to maintain current exercise routine, sleep and dietary patterns throughout the study
• Agrees to avoid high caffeine consumption 24-hours prior to study appointments (examples include but not limited to no more than 2 cups of caffeinated coffee or tea)
• Agrees to avoid alcohol consumption 24-hours prior to study appointments

You may not qualify if:

• Women who are pregnant, breast feeding, or planning to become pregnant during the study
• Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients
• Dementia and/or cognitive decline or use of prescribed medications used to for dementia and/or cognitive decline (Section 6.3.1)
• Prescribed medications for depression that may affect concentration, attention and performance as assessed by the QI (Section 6.3.1)
• Current use of supplements used for cognition or mood support unless on a stable dose (Section 6.3.2)
• History of epilepsy, brain injury or trauma as assessed by the QI
• Self-reported confirmation of sleep disorder as assessed by the QI
• Prescribed or over-the-counter medications or supplements used for sleep (Section 6.3.1 and 6.3.2)
• Self reported colour-blindness
• Prescribed use of antibiotics within 1 month of baseline (Section 6.3.1)
• Prescribed use of anticoagulants/antiplatelets (Section 6.3.1)
• Prescribed or chronic use of over-the-counter anti-inflammatory medications (Section 6.3.1 and 6.3.2)
• Current use of supplements containing the ingredients in the IP unless willing to washout (Section 6.3.2)
• Current employment that calls for rotating shift work or shift work that will disrupt normal circadian rhythm in the last 3 weeks
• Travelled across 1 or more time zones in the last 3 weeks and/or is anticipating more travel during the study

Sponsors & Collaborators

• Researched Nutritionals LLC: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6A5R8, Canada

Location

Study Officials

• David Crowley, M.D.

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 27, 2021
• Study Start: April 27, 2021
• Primary Completion: September 10, 2021
• Study Completion: September 10, 2021
• Last Updated: April 28, 2022

Record last verified: 2022-04

Locations

CA (1)