We retrospectively identified patients diagnosed with Alzheimer’s disease (AD) attending the Alzheimer Disease Center and Memory Clinic of the Instituto Andaluz de Neurociencia (IANEC), Málaga, Spain, between January 2017 and December 2020. We selected AD patients from the IANEC memory clinic records. For the diagnosis of AD, the criteria established by the National Institute on Aging Alzheimer’s Association workgroups (NIA/AA) were followed. To be included in the study AD patients had to be at stage 3 or 4 of the Reisberg Global Deterioration Scale (GDS) [27 (link)]. These GDS stage are a criterion to prescribe Souvenaid at the IANEC memory clinic.
The researchers collected data from the patients’ medical history. All selected participants were asked to allow data collection on their medical history. In addition to demographic and clinical characteristics, information on treatment with Souvenaid alone or AChEI alone or both substances combined, neurological and psychiatric data, neuropsychological evaluation, and magnetic resonance imaging (MRI) were collected. These evaluations are included in the routine examinations that patients undergo every six months at the IANEC.
We excluded patients who presented focal neurological signs, epileptic seizures, brain inflammation, uncontrolled psychiatric disorders, incomplete medical chart, and sensory impairments such as severe vision and hearing impairment disorders.
We considered as candidates those patients who had received treatment for 12 months with any of the following medications: Souvenaid (1 dose per day), donepezil (10 mg per day), galantamine (16 or 24 mg per day), or rivastigmine patch (9.5 or 13.3 mg per day). Patients were classified into three groups according to the treatment followed: Souvenaid alone, AChEI alone, or Souvenaid plus AChEI. Patients also were receiving stable doses of other classes of medications including antihypertensives (39.1%), anticoagulants (4.2%), calcium channel blockers (11.4%), diuretics (18.3%), lipid reducing agents (35.6%), and antidiabetic drugs (19.6%).
During the study period, a total of 332 patients with AD were identified. Of these 332 subjects, 28 potential participants were not included because they had no sufficient data in their medical charts, 20 were unable to be contacted, 17 declined or did not meet the inclusion criteria (n = 47).
As this was a retrospective study, the sample size was not determined a priori. The study was approved by the Málaga Local Ethics Committee and a written informed consent was signed by patients or their legal representative. The study was guided by the ethical standards adopted by the XVIII World Medical Assembly Declaration of Helsinki and subsequent revisions.
The researchers collected data from the patients’ medical history. All selected participants were asked to allow data collection on their medical history. In addition to demographic and clinical characteristics, information on treatment with Souvenaid alone or AChEI alone or both substances combined, neurological and psychiatric data, neuropsychological evaluation, and magnetic resonance imaging (MRI) were collected. These evaluations are included in the routine examinations that patients undergo every six months at the IANEC.
We excluded patients who presented focal neurological signs, epileptic seizures, brain inflammation, uncontrolled psychiatric disorders, incomplete medical chart, and sensory impairments such as severe vision and hearing impairment disorders.
We considered as candidates those patients who had received treatment for 12 months with any of the following medications: Souvenaid (1 dose per day), donepezil (10 mg per day), galantamine (16 or 24 mg per day), or rivastigmine patch (9.5 or 13.3 mg per day). Patients were classified into three groups according to the treatment followed: Souvenaid alone, AChEI alone, or Souvenaid plus AChEI. Patients also were receiving stable doses of other classes of medications including antihypertensives (39.1%), anticoagulants (4.2%), calcium channel blockers (11.4%), diuretics (18.3%), lipid reducing agents (35.6%), and antidiabetic drugs (19.6%).
During the study period, a total of 332 patients with AD were identified. Of these 332 subjects, 28 potential participants were not included because they had no sufficient data in their medical charts, 20 were unable to be contacted, 17 declined or did not meet the inclusion criteria (n = 47).
As this was a retrospective study, the sample size was not determined a priori. The study was approved by the Málaga Local Ethics Committee and a written informed consent was signed by patients or their legal representative. The study was guided by the ethical standards adopted by the XVIII World Medical Assembly Declaration of Helsinki and subsequent revisions.
