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Diet

Therapeutic Diets for Alzheimer's Disease (TDAD Trial)

N/A

Recruiting

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 50 to 90

Be older than 18 years old

Must not have

A potentially confounding serious medical risk including insulin-requiring diabetes, cancer requiring chemotherapy or radiation within the past 5 years, or a recent cardiac event (i.e. heart attack, angioplasty, etc.)

A history of renal stones

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks, 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how two different diets affect thinking and memory in people with Alzheimer's disease.

Who is the study for?

This trial is for individuals aged 50 to 90 with Alzheimer's Disease, as diagnosed by McKhann et al. criteria. Participants must speak English, have a stable medication regimen for the past month, and score 0.5 or 1 on the CDR scale. They need a study partner and cannot be in nursing care or another trial, nor can they have renal stones, insulin-requiring diabetes, recent cancer treatments or cardiac events.

What is being tested?

The study aims to compare how two diets—the Ketogenic Diet and Therapeutic Lifestyles Changes Diet—affect cognitive function in Alzheimer's patients. Researchers will observe changes in cognition to determine any potential benefits of these dietary interventions.

What are the potential side effects?

Potential side effects from these diets may include digestive issues like constipation or diarrhea due to changes in food intake. The ketogenic diet might also cause low blood sugar levels, fatigue during initial adjustment periods, and possibly an increased risk of kidney stones.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 50 and 90 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have serious health issues like insulin diabetes, recent cancer treatments, or heart problems.

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I have had kidney stones in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks, 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 weeks, 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Clinical Dementia Rating (CDR)

Change in cognitive performance by Stroop test

Change in cognitive performance on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADASCog11)

+2 more

Secondary study objectives

Change in blood platelet mitochondrial function

Change in cerebral concentration of N-Acetylaspartate (NAA)

Change in self-reported symptoms by study partner

Other study objectives

Change in blood ketone levels induced by ketogenic diet

Dietary intake characterization prior to and after ketogenic diet initiation

Proportion of days positive for urinary ketone production

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Ketogenic DietExperimental Treatment1 Intervention

Study partners will be instructed to assist participants in adherence to a 1:1 ketogenic diet (approximately 70% fat, \<10% carbohydrate, and 20% protein as energy). The diet will encourage ≥4 servings of non-starchy vegetables and 1/2 cup of berries daily. Participants will be provided an emulsified medium chain triglyceride supplement with a target intake of 1-2 tablespoons per day and micronutrient supplements consisting of multivitamin, vitamin D, calcium, and phosphorus. After the 3-month ketogenic diet, participants will complete a 1-month washout period in which they halt adherence to the ketogenic diet and resume their normal diet.

Group II: Therapeutic Lifestyles Changes DietActive Control1 Intervention

Study partners will be instructed to assist participants in adherence to the Therapeutic Lifestyles Changes diet. The diet consists of 20-35% fat, 50-60% carbohydrate, and \~15% protein as energy. Fat intake will comprise \<7% saturated fat, ≤20% monounsaturated fat, and ≤10% polyunsaturated fat as total energy. Cholesterol consumption will be ≤200mg per day. Participants are encouraged to eat ≥2 servings of fruit and ≥5 servings of vegetables per day.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketogenic Diet

2016

Completed Phase 2

~460

0 / 3Eligibility criteria met