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Creatine to Augment Bioenergetics in Alzheimer's (CABA)

Primary Purpose

Alzheimer's Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Creatine Monohydrate
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed cognitive impairment due to Alzheimer's disease
  • Agreed cooperation from a study partner
  • Speaks English as primary language
  • Age 60 to 90
  • Stable medication for ≥30 days
  • BMI ≥ 20.0kg/m2

Exclusion Criteria:

  • Insulin-requiring diabetes, cancer requiring chemotherapy or radiation within the past 5 years, or recent cardiac event (i.e., heart attack, etc.)
  • Other neurodegenerative disease
  • Ongoing renal disorder or abnormal renal or liver function
  • Unable to undergo MRI
  • Clinical trial or investigational drug or therapy participation within 30 days of the screening visit
  • Non-English speakers
  • Inability to perform strength testing
  • Weight > 350 lbs.

Sites / Locations

  • University of Kansas Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Creatine Monohydrate Arm

Arm Description

This study a single arm intervention. All participants will receive 20 grams of creatine monohydrate daily for the whole intervention (8 weeks).

Outcomes

Primary Outcome Measures

Adherence to Creatine Monohydrate Intervention
Participants will keep a daily supplement tracker (with the help of a consenting study partner). They will also bring unconsumed creatine monohydrate powder to study visits where study personnel will measure and validate against expected intake.
Change in Blood Creatine
Measure of serum creatine levels at baseline, 4 weeks, and 8 weeks.

Secondary Outcome Measures

Change in Brain Creatine Status
Brain total creatine levels are measured in the brain using magnetic resonance spectroscopy in a 3 T clinical scanner.
Change in Cognition
NIH Toolbox (NIH-TB) Cognition Battery will be used to assess changes in a composite global cognition score at baseline and 8 weeks.
Change in Peripheral Mitochondrial Respiration
Blood platelet and leukocyte mitochondrial respiration (oxygen consumption) will be determined using the Oroboros Oxygraph-2K system.
Change in Muscle Strength
Muscle strength will be tested on the right quadriceps femoris (upper leg) using an isokinetic dynamometer.
Change in Muscle Size
Muscle size of the right quadriceps femoris (upper leg) will be determined using ultrasonography (ultrasound).

Full Information

First Posted
April 20, 2022
Last Updated
January 9, 2023
Sponsor
University of Kansas Medical Center
Collaborators
Alzheimer's Association
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1. Study Identification

Unique Protocol Identification Number
NCT05383833
Brief Title
Creatine to Augment Bioenergetics in Alzheimer's
Acronym
CABA
Official Title
Creatine to Augment Bioenergetics in Alzheimer's
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2022 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center
Collaborators
Alzheimer's Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
By doing this study, researchers hope to see if creatine monohydrate is a helpful treatment for people with Alzheimer's disease.
Detailed Description
Alzheimer's disease is a progressive brain disorder that causes memory and thinking problems. Current medications may temporarily help with symptoms but cannot stop the disease from getting worse. As such, new treatments that slow or stop the disease from progressing are needed. There is some evidence from animal studies that taking creatine monohydrate may improve thinking in Alzheimer's disease and be good for brain health. However, no studies have looked at creatine monohydrate supplementation in humans with Alzheimer's. Creatine monohydrate is a dietary supplement regulated by the FDA. This is a study that will test if taking creatine monohydrate may be a helpful treatment for people with Alzheimer's disease. In this study, investigators will will evaluate: Whether persons with Alzheimer's disease are able to easily take creatine monohydrate for 8 weeks. Whether creatine monohydrate affects thinking function in people with Alzheimer's Disease. Whether creatine monohydrate affects certain biochemicals in the brain and body. Whether creatine monohydrate improves muscle size and strength.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Creatine Monohydrate Arm
Arm Type
Experimental
Arm Description
This study a single arm intervention. All participants will receive 20 grams of creatine monohydrate daily for the whole intervention (8 weeks).
Intervention Type
Dietary Supplement
Intervention Name(s)
Creatine Monohydrate
Intervention Description
Participants will take 20 grams of creatine monohydrate daily for 8 weeks.The 20 grams will be divided into two equal 10 gram doses that will be stirred into a beverage. One 10 gram dose will be taken in the morning and the other 10 gram dose in evening.
Primary Outcome Measure Information:
Title
Adherence to Creatine Monohydrate Intervention
Description
Participants will keep a daily supplement tracker (with the help of a consenting study partner). They will also bring unconsumed creatine monohydrate powder to study visits where study personnel will measure and validate against expected intake.
Time Frame
8 weeks
Title
Change in Blood Creatine
Description
Measure of serum creatine levels at baseline, 4 weeks, and 8 weeks.
Time Frame
Baseline, 4 weeks, and 8 weeks
Secondary Outcome Measure Information:
Title
Change in Brain Creatine Status
Description
Brain total creatine levels are measured in the brain using magnetic resonance spectroscopy in a 3 T clinical scanner.
Time Frame
Baseline and 8 weeks
Title
Change in Cognition
Description
NIH Toolbox (NIH-TB) Cognition Battery will be used to assess changes in a composite global cognition score at baseline and 8 weeks.
Time Frame
Baseline and 8 weeks
Title
Change in Peripheral Mitochondrial Respiration
Description
Blood platelet and leukocyte mitochondrial respiration (oxygen consumption) will be determined using the Oroboros Oxygraph-2K system.
Time Frame
Baseline and 8 weeks
Title
Change in Muscle Strength
Description
Muscle strength will be tested on the right quadriceps femoris (upper leg) using an isokinetic dynamometer.
Time Frame
Baseline and 8 weeks
Title
Change in Muscle Size
Description
Muscle size of the right quadriceps femoris (upper leg) will be determined using ultrasonography (ultrasound).
Time Frame
Baseline and 8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed cognitive impairment due to Alzheimer's disease Agreed cooperation from a study partner Speaks English as primary language Age 60 to 90 Stable medication for ≥30 days BMI ≥ 20.0kg/m2 Exclusion Criteria: Insulin-requiring diabetes, cancer requiring chemotherapy or radiation within the past 5 years, or recent cardiac event (i.e., heart attack, etc.) Other neurodegenerative disease Ongoing renal disorder or abnormal renal or liver function Unable to undergo MRI Clinical trial or investigational drug or therapy participation within 30 days of the screening visit Non-English speakers Inability to perform strength testing Weight > 350 lbs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aaron N Smith, MS, RD
Phone
913-229-5935
Email
asmith71@kumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Taylor, PhD, RD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aaron Smith, MS
Phone
913-229-5935
Email
asmith71@kumc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Creatine to Augment Bioenergetics in Alzheimer's

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