Creatine to Augment Bioenergetics in Alzheimer's

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-12

Study Completion Date

2024-05-14

Brief Summary

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By doing this study, researchers hope to see if creatine monohydrate is a helpful treatment for people with Alzheimer's disease.

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Detailed Description

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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:

1. Whether persons with Alzheimer's disease are able to easily take creatine monohydrate for 8 weeks.
2. Whether creatine monohydrate affects thinking function in people with Alzheimer's Disease.
3. Whether creatine monohydrate affects certain biochemicals in the brain and body.
4. Whether creatine monohydrate improves muscle size and strength.

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Creatine Monohydrate Arm

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

Group Type EXPERIMENTAL

Creatine Monohydrate

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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Creatine Monohydrate

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No