Evaluation of the effectiveness of "Prunus dulcis" on Alzheimer's diseases

Determination and comparison of MMSE and FAST, CDR and MoCA questionnaires and the sleep questionnaire of sweet almond recipients in Alzheimer's patients ​

Clinical trial with control group with parallel groups, without blinding, randomized, 2 groups on 60 patients. Allocation concealment was used for concealment. ​

This research is designed as a clinical trial to investigate the therapeutic effect of sweet tree almonds on Alzheimer's patients. Patients diagnosed with the disease by a psychiatrist or neurologist or geriatric medicine specialist at the Iranian Alzheimer's Association complete the relevant questionnaires at the beginning and at the end of the study and receive almonds with a specific dose during the study for three months. The control group without receiving almonds, completes the questionnaire at the beginning and end of the study. ​

"Entry conditions": 1. Patients with Alzheimer's disease ; 2. Not having other psychiatric disease causing dementia other than Alzheimer's; 3. Not having severe non-psychiatric and non-neurological diseases; 4. Not abusing substances or drugs such as narcotics or stimulants; 5. Completion of written informed consent of the patient or the patient's guardian to enter the plan; "Non-entry conditions": 1. Uncontrolled diabetes mellitus because the almonds are slightly sweetened with candy

patients with mild to moderate Alzheimer's disease diagnosed as the intervention group, receive tree sweet almonds with a specified dose, and questionnaires are completed at the beginning and end of the study. Due to the open label nature of the study, the control group without receiving sweet almonds fills the questionnaires at the beginning and at the end of the study.

Change in score of MMSE and FAST ,CDR and MoCA and sleep questionnaire

In this study, we will use the block randomization method and in this two-group clinical trial, we will have 4 blocks. For each person who enters the study, a code is obtained from the software and it is determined which group (intervention or control) it belongs to. The working tool is Random Allocation Software. This software can be downloaded for free from the following address: https://random-allocation-software.software.informer.com/2.0 In the mentioned software, the number of two groups and the sample size is 100, the block method with random sizes is selected and the output is the randomization list. In order to conceal, we use specialized random Allocation concealment, this method is such that the allocated group is not known before the individual is allocated, in this way, by using opaque envelopes marked with a random sequence, which in In this method, each of the random sequences created is recorded on a card and the cards are placed in the envelopes in order. Finally, the lids of the envelopes are glued and placed in a box. Blocking and preparation of envelopes is done by a person not involved in data sampling and analysis. In this way, the person who collects, the person who analyzes, and the person who participates do not know the type of intervention received and in which group each person is placed.

All data is potentially shareable after de-identifying individuals

The access period starts 3 months after the results are published

Researchers working in academic and scientific institutions and other people

There is no limit for scientific use and exploitation of the results. However, the questionnaires of people's diseases must remain completely confidential.

For use, they can refer to the library website of the Faculty of Iranian Medicine, Iran University of Medical Sciences. Also, use the articles extracted from the research work and published in magazines.

A person should visit the library and use the results after membership or through guest membership. Also, by referring to websites related to magazines, he can access articles.