The purpose of this study is to evaluate the effectiveness of a nutritional supplement that
has been developed to improve the brain function of a patient with Alzheimer's disease.
The ability of the brain to use its major fuel, the sugar glucose, is reduced in Alzheimer's
disease. A nutritional supplement has been developed to improve the function of the
Alzheimer brain by increasing its ability to use sugar effectively. The ingredients of the
supplement are natural products, and are found in the normal American diet. Results have
been encouraging in open trials where the patients knew they were taking the active
medicine. Patients are now being invited to participate in a placebo-controlled trial
lasting 3 months, followed by a 3-month open label trial where all patients will receive the
This is a double-blind, placebo-controlled, parallel-group, 3 month trial followed by a
3-month open-label period, of a nutritional supplement designed to improve brain metabolism
and function in patients with Alzheimer's disease (AD). The design of the nutritional
supplement is based on replicated observations of abnormalities in mitochondria in AD. The
constituents of the nutritional supplement are components of the normal American diet, and
are classified by the FDA as GRAS (Generally Regarded As Safe). Results with the supplement
have been favorable in preliminary, open trials (eg mean improvement in MMSE score of +4.9,
range +3 to +8, n = 7, P <0.0004).
During the placebo-controlled portion of the trial, half of the participants will receive
the active preparation and half a sugar pill. During this first phase, neither the patients
nor those testing them will know who is taking active medicine and who is taking placebo.
The active supplement or placebo are taken as 1 tablespoon twice a day, between meals. If
desired, the supplement or placebo can be stirred into, or washed down with, water, coffee
or tea without milk or sugar, or the soft drink TAB. Patient visits to the Burke Medical
Research Institute will be once a month, after the screening and baseline visits.
The supplement is taken as one tablespoon of a fluid, between meals. Since other sugars or
citrate can be expected to interfere with the actions of the supplements, food or drinks
containing sugar or citrate and diet drinks containing citrate are to be avoided for 1 1/2
hour before and 1 1/2 hour after taking the supplement. No significant adverse events have
been associated with this supplement. However, standard precautions for patient safety are
being taken, including medical examination and clinical laboratory tests at screening and at
the completion of the double-blind and open-label phases.
Inclusion criteria include:
- A documented diagnosis of Alzheimer's disease;
- MMSE score between 10 and 26 inclusive;
- A reliable caregiver to ensure compliance.
Exclusion criteria include:
- diabetes, unstable medical illness, myocardial infarction or cancer diagnosed within
the previous 12 months, or treatment with systemic steroids.
- Patients being treated for depression or other psychiatric symptomatology are
eligible, if their symptoms are under control on a stable dose of medication