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Novel Protocol Improves Cognition, Outperforms Community Treatment of Dementia

VBCN - July 2014 Volume 1, No 2 - Alzheimer’s Disease/Dementia
Wayne Kuznar

Philadelphia, PA—A protocol that identifies reversible or modifiable contributory factors to cognitive impairment when used in combination with the aggressive use of approved antidementia medications can improve the cognitive status of patients with dementia or mild cognitive impairment.

The protocol consists of a comprehensive assessment and treatment of cognitive impairing conditions, such as hypoxia, hyperhomocysteinemia, iron deficiency, and bradycardia. The approach outperformed the standard of care received in the community on the outcome of cognition over 2 years, reported Emily F. Clionsky, MD, Chief Medical Officer, Clionsky Neuro Systems, Springfield, MA, at the 2014 American Academy of Neurology meeting.

The need for a more effective approach to managing dementia is urgent, said Dr Clionsky, because current medications have limited benefit.

Dementia Protocol
Dr Clionsky’s protocol measures heart rate and O2 status at rest and nocturnally, and homocysteine and iron levels are assessed regularly. “If a patient is hypoxic, the microvasculature will be abnormal at a molecular level,” she said. “Fix the lack of oxygen, and you’re going to help the cell itself stay stable and reduce reactive oxygen species.”

A sleep study is ordered if the patient’s score on the Memory Orientation Screening Test (MOST) is >16, and positive airway pressure treatment is started if sleep apnea is diagnosed. Memantine (Namenda) is then initiated and is followed by the addition of an acetylcholinesterase inhibitor, titrated to the highest dose tolerated without side effects.

“I take the standard antidementia drugs, and I drive them to as high a dose as I possibly can,” Dr Clionsky said. “Some patients were on rivastigmine at 19 mg before the Food and Drug Administration ever cleared the 13.3-mg dose.”

Donepezil (Aricept), which is known to slow heart rate, is avoided if the patient has bradycardia. “Before I’ll treat with an acetylcholinesterase inhibitor, I’ll fix the low heart rate,” Dr Clionsky said.

Benzodiazepines, narcotics, and sleep medications (other than eszopiclone [Lunesta]) are avoided and urinary incontinence medications are discontinued. Cognition is reassessed every 8 to 12 weeks after an intervention or a treatment change. Patients are screened for neuropathy and are treated if it is present, and supervised gait training is ordered. Exercise and social activity are prescribed, and family support is encouraged.

Improvement in Cognition
The longitudinal analysis reported here compared 362 heterogeneous patients who were managed with the protocol and a matched cohort of 280 patients receiving standard care in the community. Cognition was the primary outcome measure using the MOST.

In all, 82.6% of the protocol-managed patients were hypoxic. A total of 30% of patients had nocturnal hypoxia, and 20% showed nocturnal hypoxia during a sleep study. “More important, that same group of patients had about an 80% rate of bradycardia,” Dr Clionsky said.

In the 2-year comparison, the mean MOST score was 17.82 with the advanced protocol versus 12.12 with standard community care (P = .001). The score of 17.82 in the group treated according to the advanced dementia protocol represents a 17.3% improvement from baseline, whereas those treated in the community saw their score drop by approximately 25%.

“The results in the community care group are what we see with typical dementia drugs,” said Dr Clionsky. “We saw stabilization and improvement in the protocol group.”

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